Registration Dossier
Registration Dossier
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EC number: 202-576-0 | CAS number: 97-36-9
Endpoint summary
Administrative data
Description of key information
- oral:
KEY_401_1980_BASF_1980-05-23:
LD50, rat, male/female: 1995 mg/kg bw, reliability 2
NON KEY_401_1979_Hazleton_ 1842-733/18:
LD50, rat, male: 3000 mg/kg bw, reliability 2
LD50, rat, female: 3217 mg/kg bw, reliability 2
LD50, rat, male/female: 3094 mg/kg bw, reliability 2
NON KEY_401_1973_Consultox_CL73:91:889:
LD50, mouse, male/female: 1400 mg/kg bw, reliability 2
LD50 range finding, mouse, male: >1000, <2500 mg/kg bw, reliability 3
LD50 range finding, rat, female: >1000, <2500 mg/kg bw, reliability 3
LD50 range finding, rabbit: >1000, <2500 mg/kg bw, reliability 3
NON KEY_1992 (1975)_Eastman Kodak_278330S:
LD50, rat: 800 mg/kg bw, reliability 3
LD50, mouse: 1131 mg/kg bw, reliability 3
NONKEY_MetHb_1980_BASF_1980-05-23:
LD50, cat, male/female: approximately 200 mg/kg bw, lethality not caused by MetHb formation, reliability 2
- inhalation:
NONKEY_403_1980_ BASF_1980-05-23:
no inhalation risk, reliability 3
- intraperitoneal:
LD50, mouse, male/female: >700, < 2000 mg/kg bw, not adequate, not relevant for classification
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 995 mg/kg bw
Additional information
Testing for acute oral toxicity in different animal species (rat, mouse, rabbit) following OECD standard or company methods revealed LD50 values in a range of 800 to 3217 mg/kg bw. For the cat LD50 was approximately 200 mg/kg bw. The most reliable and most sensitive value of 1995 mg/kg came from the key study similar to OECD 401 and was related to male and female rats.
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 this result. Thus the oral LD50 value of 1995 mg/kg bw is adequate for comparison with classification criteria.
Findings of an acute inhalation risk test (no lethality, no other abnormal response) do not support classification.
Justification for classification or non-classification
The most reliable LD50 value of 1995 mg/kg bw for oral ingestion meets criteria for classification according to DIRECTIVE 67/548/EEC (2.2 DSD-DPD) or REGULATION (EC) No 1272/2008 (2.1 GHS / CLP). A classification as R22 or Cat 4, H302 is warranted.
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