Registration Dossier
Registration Dossier
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EC number: 202-044-8 | CAS number: 91-15-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- only summary available
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Phthalonitrile
- EC Number:
- 202-044-8
- EC Name:
- Phthalonitrile
- Cas Number:
- 91-15-6
- Molecular formula:
- C8H4N2
- IUPAC Name:
- benzene-1,2-dicarbonitrile
- Details on test material:
- Identity: ortho-Phtalodinitrile
Batch No.: Laufprobe 26.11.2009
CAS No.: 91-15-6
Purity: 99.51 area-% (exact value is being currently analysed, BASF study code 09L00445)
Storage: At room temperature
Expiration Date: November 26, 2011
Constituent 1
- Specific details on test material used for the study:
- Purity: 98,7 %
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Duration of treatment / exposure:
- Males, 44 days
Females, from 14 days before mating to day 4 of lactation
Doses / concentrations
- Remarks:
- 1, 6, 30 mg/kg/day
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 6 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- other: increase of total protein was observed in females of the 6 mg/kg group
- Dose descriptor:
- NOEL
- Effect level:
- 6 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
Applicant's summary and conclusion
- Conclusions:
- An increase of total protein was observed in females of the 6 mg/kg group . Body weight
gain was suppressed and decrease in food consumption was observed in males and females in
the 30 mg/kg group. All females of the 30 mg/kg group died, suffering convulsions on days 19-
23 of gestation. The males of the 30 mg/kg group showed an increase of total cholesterol and
total protein, a decrease of serum urea nitrogen, an increase in the weights of the liver, kidneys,
and testes, and a decrease in the weight of the epididymis . Histopathological examination
revealed centrilobular hypertrophy of hepatocytes in the liver, hyaline droplets in the proximal
tubular epithelium, basophilic degeneration of the renal tubules, and atrophy of the
seminiferous tubules with cell debris in the tubules in male animlas at 30 mg/kg. - Executive summary:
The NOELs for repeat dose toxicity are considered to be 1 mg/kg/day for females and 6
mg/kg/day for males .
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