DfE Neurotoxicity





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)


Dermal (mg/kg-bw/day)


Inhalation (gas) (ppm/6h/day)


Inhalation (vapor) (mg/L/6h/day)


Inhalation (dust/mist) (mg/L/6h/day)


*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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