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Toxicological information

Developmental toxicity / teratogenicity

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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

Reference
Name:
Unnamed
Type:
Constituent
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).