3.4 NEUROTOXICITY
Criteria
Chemicals that are considered neurotoxicants under GHS [15] (see GHS guidance values in Table 5) shall not pass the Criteria. Neurotoxicity is covered under Specific Target Organ Toxicity Repeated Exposure in GHS.
Table 5 – GHS Guidance Values
| Route of Exposure | Guidance Value* |
| Oral (mg/kg-bw/day) | 100 |
| Dermal (mg/kg-bw/day) | 200 |
| Inhalation (gas) (ppm/6h/day) | 250 |
| Inhalation (vapor) (mg/L/6h/day) | 1.0 |
| Inhalation (dust/mist) (mg/L/6h/day) | 0.2 |
| *The doses provided are for 90-day studies. Guidance values are tripled for chemicals evaluated in 28-day studies. |
Data Requirements
All available data, measured and/or estimated, for the chemical and/or a suitable analog will be reviewed against the criteria using a weight-of-evidence approach.
Preferred Test Methods for GHS Review
– OECD Test Guideline 424: Neurotoxicity Study in Rodents [45] and
– OPPTS Harmonized Guideline 870.6200: Neurotoxicity screening battery [1].
Additional Test Methods for GHS Review
Additional evidence from OECD Test Guideline 426: Developmental Neurotoxicity Study [46] and OPPTS Harmonized Guideline: 870.6300 Developmental neurotoxicity study [47] can be used to screen chemicals for neurotoxicity.
Data Interpretation
– Section 3, Hazard Characterization in Guidelines for Neurotoxicity Risk Assessment [48], and
– GHS Ch. 3.9 Specific Target Organ Toxicity Repeated Exposure [49].
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