Registration Dossier

Administrative data

Description of key information

- oral:
LD50 rat: 6951 mg/kg bw, reliability 2,
LD50 cat: >500 mg/kg bw, reliability 2
- inhalation:
LC50 rat: 2.5 mg/L, reliability 4
- dermal: >2000 mg/kg bw, reliability 4

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
6 951 mg/kg bw

Additional information

Testing of acute oral toxicity in rat and cat following an OECD like protocol or company methods revealed LD50 values of 6951 mg/kg bw for the rat and >500 mg/kg bw for the cat. Inhalation and dermal toxicity data are only available from secondary literature (reliabilit 4) and provide an LC50 of ca. 2.5 mg/L for inhalation and an LD50 of >2000 mg/kg bw for dermal exposure.

No definite indications for a relevant MetHb formation or MetHb caused lethality were observed in any of these studies that might affect the assessment of human relevance of these findings. Thus valid LD50 or LC50 values were adequate for direct comparison with classification criteria.

Justification for classification or non-classification

The substance is listed in Annex VI to regulation (EC) No 1272/2008 but is not classified related to acute toxicity. Data presented here are not contradictory to that since oral and dermal LD50 values do not correspond with criteria for classification and since reliability of inhaltion toxicity date is not assignable. In conclusion based on the available data presented here no adjustment of classification is warrantable.

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