Registration Dossier
Registration Dossier
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EC number: 251-607-4 | CAS number: 33629-47-9
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 83-4 (Reproduction and Fertility Effects)
- GLP compliance:
- not specified
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
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- acetone
- Duration of treatment / exposure:
- 11 weeks before mating for two-week period.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 ppm
- Dose / conc.:
- 300 ppm
- Dose / conc.:
- 1 000 ppm
- No. of animals per sex per dose:
- 10 males
20 females
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No F0 parental animals died; F0 male body weights were reduced for all time points measures, weeks 4, 9, 11, and 21 at 300 and 1000 ppm and only for week 4 at 100 ppm.
None of the observations recorded for the F0 parents was such as to suggest a dose relationship. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- F0 male body weights were reduced for all time points measures, weeks 4, 9, 11, and 21 at 300 and 1000 ppm and only for week 4 at 100 ppm.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption was unaffected.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 100 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No F0 parental animals died; F0 female body weights reduction were observed.
Effect levels (P1)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 100 ppm
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 100 ppm
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F2 generation
Effect levels (F2)
- Key result
- Dose descriptor:
- LOAEL
- Generation:
- F2
- Effect level:
- ca. 100 ppm
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Exposure of Technical Butralin in te diet to rats at concentration of 0, 100, 300 or 1000 ppm for three generations (two litters per generation) resulted in adult toxicity (reduced body weight) at 300 and 1000ppm. There were no effects on reproductve performance at any mating in any generation at any dose level. Post natal survival was reduced at 1000 ppm for F1a, F2b, F3a and F3b but not F1b or F2a litters (and at 300 ppm for F3b litters only) and pup body weights were reduced (not statiscally significantly) at 1000 ppm on postnatal day 21 for F1a, F1b, F2a, F2b and F3a (but not F3b) liters. The NOEAL for parental and offspring toxicity was 100 ppm in this study.
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