Registration Dossier
Registration Dossier
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EC number: 400-830-7 | CAS number: 104810-48-2 EVERSORB 80; TINUVIN 1130; TINUVIN 213
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliance
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
- EC Number:
- 400-830-7
- EC Name:
- A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
- Cas Number:
- 104810-48-2
- Molecular formula:
- (C2H4O)nC38H40N6O5
- IUPAC Name:
- A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
- Reference substance name:
- A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene) α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
- IUPAC Name:
- A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene) α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
Constituent 1
Constituent 2
Test animals
- Species:
- other: Rat (Tif: RAlf (SPF))
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: PEG 300
- Details on exposure:
- Method of administration or exposure: Gavage
- No. of animals per sex per dose:
- Number of dams and doses
24 at 0 mg/kg or mg/l
24 at 1 mg/kg or mg/l
24 at 30 mg/kg or mg/l
24 at 150 mg/kg or mg/l
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
No deaths treatment-related occured. Maternal bodyweight gain was reduced at 150 mg/kg.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Effects on fetus - Gross:
There were no dead or absorbed foetuses. Numbers of live foetuses/litter and foetal weights were comparable between the groups.
Effects on fetus - Soft tissue:
Enlarged thymus was observed in a small group of foetuses from all groups. Accessory lobulets on the liver were observed in 2, 2 and 1 foetuses of groups 2, 3 and 4 respectively.
Efects on fetus - Skeletal:
No skeletal malformations werde observed. A significant increase in the incdence of litters affected with asymmetrically shaped sternebra-5 in group 4. This was attibuted to delayed ossification, related to maternal toxicity.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
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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