Registration Dossier
Registration Dossier
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EC number: 251-607-4 | CAS number: 33629-47-9
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- EPA regulations: Pesticide Assessment Guidelines (5400-9 - 82.025)
- Principles of method if other than guideline:
- EPA regulations: Pesticide Assessment Guidelines (5400-9 - 82.025)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- EC Number:
- 251-607-4
- EC Name:
- 4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
- Cas Number:
- 33629-47-9
- Molecular formula:
- C14H21N3O4
- IUPAC Name:
- N-sec-butyl-4-tert-butyl-2,6-dinitroaniline
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- m-xylene
Constituent 1
impurity 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- CMC (carboxymethyl cellulose)
- Duration of treatment / exposure:
- 3 weeks
- Frequency of treatment:
- Once daily from day to 15 of gestation
Doses / concentrations
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Spleen: nodule
Yellow colouration of the adipose tissues
Effect levels (maternal animals)
- Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- External malformations:
- effects observed, non-treatment-related
Effect levels (fetuses)
- Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
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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