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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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:
2004
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Principles of method if other than guideline:
Method: other: test on maternal toxicity and teratogenicity
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
IUCLID4 Test substance: other TS: food additive grade

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).