Registration Dossier
Registration Dossier
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EC number: 202-044-8 | CAS number: 91-15-6
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- 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
- 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:
- I- Name of test material (as cited in study report): phthalonitrile
- Analytical purity: pure
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 bw/day
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All females of the 30 mg/kg group died, suffering convulsions on days 19-23 of gestation.
- Description (incidence and severity):
- Body weight gain was suppressed in males and females in the 30 mg/kg group.
- Description (incidence and severity):
- A decrease in food consumption was observed in males and females in the 30 mg/kg group.
- Description (incidence and severity):
- 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 of total protein was observed in females of the 6 mg/kg group.
- Description (incidence and severity):
- The males of the 30 mg/kg group showed an increase of total cholesterol and
total protein, a decrease of serum urea nitrogen. - Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- 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 rats at the 30 mg/kg/day group.
Details on results (P0)
copulation index, fertility index, number of corpora lutea, number of implantations, or the
implantation index. As all dams from the 30 mg/kg group died in late pregnancy, no data were obtained after delivery. In the 6 mg/kg group, no changes due to administration of the compound were observed with respect to the delivery index, gestation index, gestation length, parturition state, and lactation behavior.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Remarks on result:
- other: decrease in the weight of the epididymis
- Dose descriptor:
- NOAEL
- Effect level:
- 6 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- haematology
- Remarks on result:
- other: mortality at 30 mg/kg bw/day and increase of total protein was observed in females of the 6 mg/kg group
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 6 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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