Registration Dossier
Registration Dossier
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EC number: 424-460-0 | CAS number: 283167-56-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 424-460-0
- EC Name:
- -
- Cas Number:
- 283167-56-6
- Molecular formula:
- C7 H10 N2 x 0.77 H3 P O4
- IUPAC Name:
- N1-methylbenzene-1,2-diamine; phosphoric acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Among females of the 100 mg/kg dose group, no indication of a decreased functional ability of the liver was detected.
Therefore, from the results presented in this report a No Observed Adverse Effect Level (NOAEL) of 100 mg/kg/day was concluded.
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