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Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

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:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes

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: Albino rats Tif: RAlf (SPF), hybrids of RII

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5% CMC and 0.1% Tween 80
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 10 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 10 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No clinical symptoms related to the administration of the test article and no signs of systemic toxicity were observed during the study.

Laboratory findings: the finding in treated groups were unremarkable and comparable to those of the controls. The investigations revealed a minimal higher ativity of alkaline phosphatase in the male of group 4 (250 mg/kg) and male and females of the high dose group (1000 mg/kg).

Effects in organs:
- Eye examinations performed before and towards the end of the treatment period revealed no evidence of reaction to the treatment.
- A trend to slightly increased liver weights was observed in treated males group 4 and 5 (250+1000 mg/kg) and in females group 5.
- Macroscopical and microscopical examination revealed no changes which could be attributed to effects of the test compound.

No toxic effect level: 50 mg/kg bw.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
250 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Not classified.