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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Data provided by ECHA - information from migrated NONS file as per inquiry 06-0000021296-70-0000.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 414 (12 May 1981)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4,6-bis(octylthiomethyl)-o-cresol
EC Number:
402-860-6
EC Name:
4,6-bis(octylthiomethyl)-o-cresol
Cas Number:
110553-27-0
Molecular formula:
C25H44OS2
IUPAC Name:
4,6-bis(octylthiomethyl)-o-cresol

Test animals

Species:
other: Sprague Dawley Crl: CD(SD)BR rats

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
arachis oil
Details on exposure:
Method of administration or exposure: gavage
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Number of dams and doses

25 at 0 mg/kg or mg/L
25 at 50 mg/kg or mg/L
25 at 150 mg/kg or mg/L
25 at 300 mg/kg or mg/L
Control animals:
not specified
Details on study design:
no data

Examinations

Maternal examinations:
no data
Ovaries and uterine content:
no data
Fetal examinations:
no data
Statistics:
no data
Indices:
no data
Historical control data:
no data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no data

Details on maternal toxic effects:
The dose level of 300 mg/kg elicited slight maternal toxicity (slightly reduced body weight gain and, possibly, slightly reduced food consumption)

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no data

Details on embryotoxic / teratogenic effects:
Effects on fetus:
An external malformation as micrognathia was found in one foetus of group 2 (50 mg/kg). A further foetus in second litter of the same dose group showed bllateral anophtaimia. In group 3 (150 mg/kg) one foetus with apodia was observed.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion