4,6-bis(octylthiomethyl)-o-cresol

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not specified

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: Annex V, B7

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

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), hibrlds of RII

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: Distilled water containing 0.5% CMC and 0.1%Tween 80

Details on oral exposure:

Method of administration:
orally by gavage

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Dosing regime: 7 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 10, 50, 250, 1000 mg/kg b.w.
Basis:
nominal in water

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/lMale: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 ing/kg bw/day
Female: 5 animals at 10 Jilg/lFemale: 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

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

Clinical observations:
No clinical symptoms related to the administration of the
test artcle and no signs of systemic toxicity were observed
during the study
Laboratory findings: .
The finding in treated groups were unremarlcomparable to those of the controls.
The Investigations revealed a minimal higher activity 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 body weight

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

250 mg/kg bw/day (nominal)

Sex:

male/female

2

Dose descriptor:

NOEL

Effect level:

50 mg/kg bw/day (nominal)

Sex:

male/female

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No toxic effect level (NOEL) caused by the test substance in a 28-day study on rats was 50 mg/kg b.w. No death occurred during the study.