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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP (taken from SNIF file). Registrant refering to studies >12 years old at the permission of ECHA.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
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:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on exposure:
Method of administration or exposure: gavage
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/1
25 at 50 mg/kg or mg/1
25 at 150 mg/kg or mg/l
25 at 300 mg/kg or mg/l

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
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:
Details on embryotoxic / teratogenic effects:
Effects on fetus - Gross:
An external malformation as micrognathia was found in one foetus of group 2 (50 mg/Kg). A further foetus in a second litter of the same dose group showed bilateral anophtalmia. 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

Conclusions:
In the highest dosage group as well as in the control group no malformations were found. The test substance is not considered to pose a teratogenic hazard. No classification is applicable.
Executive summary:

In the highest dosage group as well as in the control group no malformations were found. The test substance is not considered to pose a teratogenic hazard. No classification is applicable.