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Part I: Toxicology Summary Information to be Included in AD and TPS

1. LD₅₀ (Oral, Dermal) Studies

The mandatory information to be included:

• LD₅₀ value and units as given in the study
• species
• route of administration
• if the study is to be used for classification purposes state if it conforms to an OECD test guideline, e.g., 401, 402, 420

Information to be included if it is available:

• number of decedents/total when a “> or <” value is reported
• convert units to mg/kg when ml/kg values are given, and provide the density or specific gravity used for the calculation

2. LC₅₀ (Inhalation) Studies

The mandatory information to be included is:

• LC₅₀ value and units
• species
• duration of exposure in hours
• conversion of LC₅₀ value to four hour equivalent if determined for a different exposure duration (CPR 44)
• saturated vapour concentration for LC₅₀s within the classification range for substances tested as vapour (CPR 46)
• if the study is to be used for classification purposes state if it conforms to an OECD test guideline, e.g., 403
• form of chemical – i.e., mist, vapour, dust, aerosol, gas

Information to be included if it is available:

• number of decedents/total when a “> or <” value is reported

3. Skin/Eye Irritation Studies

The mandatory information to be included is:

• irritant qualities, severity of effect
• species
• volume applied
• duration of skin exposure
• concentration of solution
• specify the protocol or test guideline, e.g., Draize
• if the study is to be used for classification purposes state if it conforms to an OECD test guideline, e.g., 404, 405

Information to be included if it is available:

• irritation score/max. score
• when classifying skin irritation using OECD test data, separate the available scores into erythema and edema
• when classifying eye irritation using OECD test data, separate the available scores into corneal, iris, and conjunctival swelling or redness
• for eye irritation studies include if the eyes were washed or unwashed

4. Corrosion Studies

The mandatory information to be included is:

1. Human Evidence
   • describe the report including: brief description of the study and the resultant visible necrosis of the skin, number of persons, duration of skin exposure
2. Animal Evidence
   • irritant qualities, severity of effect
   • species
   • volume applied
   • duration of skin exposure
   • concentration of solution
   • if the study is to be used for classification purposes state if it conforms to an OECD test guideline, e.g., 404, 405

Information to be included if it is available:

• irritation score/max. score
• specify the protocol or test guideline, e.g., Draize

5. Chronic/Sub-Chronic/Short-Term Toxicity

The mandatory information to be included is:

• species, sex(es), route, duration of dosing, dose levels, dosing schedule
• group size
• brief description of serious adverse effects observed at specific dose(s), and indication if effects occur in a dose-dependent manner
• if the study is to be used for classification purposes indicate which of the described effects are statistically significant
• for inhalation studies indicate whether the chemical was respirable, the size of the particles/droplets for aerosols, and the form of the chemical, type of exposure (nose-only, whole body)
• if the study is to be used for classification purposes state if it conforms to an OECD test guideline, e.g., 408, 409, 411, 413, 452

Information to be included if it is available:

• if the study is to be used for disclosure purposes indicate which of the described effects are statistically significant

6. Carcinogenicity

The mandatory information to be included is:

• a sentence stating that the ingredient is listed on the ACGIH (A1, A2, A3) or IARC (Groups 1, 2A, 2B) list and specify the category
• add an italicized note for ingredients which produce tumorigenic effects (e.g., NTP studies), but are not on the IARC or ACGIH lists, and summarize the information under chronic/sub-chronic/short-term toxicity and include for disclosure

7. Teratology/Fetotoxicity/Developmental

The mandatory information to be included is:

• species, group size, route, dosing period, dose levels
• description of maternal toxicity (specify) and at which dose levels it was observed (state if none observed or not discussed)
• brief description of adverse effects in the fetus (CPR 53) observed in relation to maternally toxic dose
• if the study is to be used for classification purposes indicate which of the described effects are statistically significant
• if the study is to be used for classification purposes state if it conforms to an OECD test guideline, e.g., 414, 415, 416

Information to be included if it is available:

• if the study is to be used for disclosure purposes, indicate which of the described effects are statistically significant (both maternal and fetal)

8. Reproductive Toxicity

The mandatory information to be included is:

1. Human Evidence
   • describe the report including: specification of the adverse effect or sterility, the sex affected, numbers of persons affected, duration of exposure, occupational environment
2. Animal Evidence
   • species, sex(es), group size, route, dosing duration, dose levels, dosing schedule, brief description of the mating procedure
   • brief description of the adverse effects in either or both sex(es) and dose(s) at which effects occur
   • for ingredients that produce fetotoxicity in a reproduction study, refer to the section on teratology/fetotoxicity for summary details required
   • if the study is to be used for classification purposes state if it conforms to an OECD guideline, e.g., 415, 416

9. Mutagenicity – In Vivo Heritable Mutation

The mandatory information to be included is:

1. Human Evidence
   • describe the report including: specification of the heritable mutagenic effect, duration and route of exposure, affected sex, numbers of persons affected (≥2 required for classification)
2. Animal Evidence
   • species, sex, group size, route, dosing duration, dose level(s), type of assay performed
   • brief description of mutagenic effects produced
   • if the study is to be used for classification purposes state if it conforms to an OECD guideline, e.g., 478, 483, 485

10. Respiratory Sensitizers

The mandatory information to be included is:

• describe the report including: brief description of the study and adverse effect produced, brief description of the occupational history of the worker (e.g., increase in severity of attacks, absence of symptoms away from work), numbers of affected persons (≥2 required for classification), duration of exposure, occupational environment
• indicate whether or not workers were identified as being atopic, or state that atopy was not discussed in the reference

11. Dermal Sensitization

The mandatory information to be included is:

1. Human Evidence
   • describe the report including: brief description of the study and the effect produced, number of persons (≥2 required for classification), duration of exposure, occupational environment
   • indicate that workers were identified as being non-atopic, or state that atopy was not discussed in the reference

Information to be included if it is available:

• brief description of the occupational history of the worker (e.g., increase in severity of attacks, absence of symptoms away from work)

2. Animal Evidence
   • species, numbers of animals, name of test method used, severity of sensitization reaction, proportion of animals sensitized, if an adjuvant was used
   • if the study is to be used for classification purposes state if it conforms to an OECD guideline, e.g., 406

12. Mutagenicity – In Vivo Somatic Mutation

The mandatory information to be included is:

• species, sex, group size, route, dosing duration, dose level(s), type of assay performed.
• brief description of mutagenic effects produced
• if the study is to be used for classification purposes state if it conforms to an OECD guideline, e.g., 474, 475, 484, 486

13. Mutagenicity – In Vitro Mutation (DISCLOSURE ONLY)

The mandatory information to be included is:

• type (name) of the assay, type of cell (i.e., mammalian, yeast, bacterial), result (positive/negative) with or without metabolic activation (S-9)

14. Human Effects of Acute/Chronic Exposure (SCHEDULE I – DISCLOSURE ONLY)

The mandatory information to be included is:

• route of exposure
• symptoms grouped by system affected (e.g., central nervous system, peripheral nervous system, blood/circulatory, gastro-intestinal, liver, respiratory, kidney, ocular, skin)
• for each grouping, provide a brief summary of the principal effects/symptoms that apply (in parenthesis)
• specify conditions of exposure (e.g., accidental poisoning) if applicable

Information to be included if it is available:

• dose or amount or level of exposure

15. Animal Effects of Acute Exposure (SCHEDULE I – DISCLOSURE ONLY)

The mandatory information to be included is:

• route of exposure
• species
• to the extent possible, symptoms grouped by system affected (e.g., central nervous system, peripheral nervous system, blood/circulatory, gastro-intestinal, liver, respiratory, kidney, ocular, skin)
• provide a brief summary of the principal effects/symptoms that apply to each grouping (in parenthesis)

Information to be included if it is available:

• dose

16. Toxicological Synergisms

The mandatory information to be included is:

• species, occupational route of exposure of controlled product or ingredient (other chemical in the interaction can be given by any route of exposure)
• a brief description of synergistic effects (must be greater than the sum of their separate effects) observed

Information to be included if it is available:

• dose, dosing period