Registration Dossier
Registration Dossier
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EC number: 418-280-1 | CAS number: 18600-59-4 CYASORB(R) UV-3638 LIGHT STABILISER
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EC Annex V,B.7
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)
- EC Number:
- 418-280-1
- EC Name:
- 2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)
- Cas Number:
- 18600-59-4
- Molecular formula:
- C22H12N2O4
- IUPAC Name:
- 2-[4-(4-oxo-4H-3,1-benzoxazin-2-yl)phenyl]-4H-3,1-benzoxazin-4-one
Constituent 1
Test animals
- Species:
- other: Sprague-Dawley (Crl: CD VAF)
- Strain:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: methylcellulose
- Details on exposure:
- Method of administration or exposure: 7 days a week by gavage from start to euthanasia.
- Analytical verification of doses or concentrations:
- not specified
- Frequency of treatment:
- Dosing regime (males): 7days/week
Dosing regime (females): 7days/week
- No. of animals per sex per dose:
- Male: 30 animals at 0 mg/kg or mg/l
Male: 30 animals at 10 mg/kg or mg/l
Male: 30 animals at 150 mg/kg or mg/l
Male: 30 animals at 1000 mg/kg or mg/l
Female: 30 animals at 0 mg/kg or mg/l
Female: 30 animals at 10 mg/kg or mg/l
Female: 30 animals at 150 mg/kg or mg/l
Female: 30 animals at 1000 mg/kg or mg/l
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
dose nr. of life pups/litter (day 0)
0 15.3
10 16.5
150 15.7
1000 15.8
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
Results: F1 generation
Details on results (F1)
No treatment related findings.
dose F1 sex ratio viability index
0 51.9 96.9%
10 50.3 98.1%
150 52.8 97.6%
1500 49.1 96.2%
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 500 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- viability
- other: sex ratio
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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