Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-881-4 | CAS number: 128-37-0
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:
- other: acceptable, documented study report, which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- other: MAK review, 2004
- Title:
- Unnamed
- Year:
- 2 004
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
- Principles of method if other than guideline:
- Method: other: test on maternal toxicity and teratogenicity
- GLP compliance:
- not specified
Test material
- Details on test material:
- IUCLID4 Test substance: other TS: food additive grade
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: JCL-ICR
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Duration of treatment / exposure:
- day 7 to 13 of gestation
- Frequency of treatment:
- once a day
- Duration of test:
- animals were killed on day 18 of gestation
- No. of animals per sex per dose:
- 26-30 females per group
- Control animals:
- other: yes, concurrent vehicle and concurrent untreated
- Details on study design:
- Sex: female
Duration of test: until the 18th day of gestation
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 240 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: developmental toxicity
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
RS-Freetext:
800 mg/kg bw day:
MATERNAL PARAMETER: increased spleen weight; decreased kidney weight (compared to the untreated control animals)
REPRODUCTIVE PARAMETERS: no effects
FETAL PARAMETER: no effects
240 mg/kg bw day:
MATERNAL PARAMETER: no effects
REPRODUCTIVE PARAMETERS: no effects
FETAL PARAMETER: no effects
70 mg/kg bw day:
MATERNAL PARAMETER: no effects
REPRODUCTIVE PARAMETERS: no effects
FETAL PARAMETER: no effects
Applicant's summary and conclusion
- Executive summary:
Due to the findings of this study, the author concluded, that BHT was not teratogenic to JCL-ICR mice. Dams treated with 800 mg/kg bw and day showed an increased spleen weight and recuced kidney weight (Hiraga 1978).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
