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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

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:

C25 H44 O S2

IUPAC Name:

2-methyl-4,6-bis[(octylsulfanyl)methyl]phenol

Details on test material:

- Storage: room temperature
- Physical state: liquid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF) hybrids of RII 1/Tif x RII 2/Tif (albino)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 216 - 270 g (within ± 20 % of mean value)
- Housing: caged individually in Macrolon cages type 3 with standardised soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet: ad libitum; Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water: ad libitum
- Acclimation period: 22 days
- Rational for choice: the rat has been selected for this test as being a standard species for the determination of an acute dermal LD50.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
- % coverage: no data
- Type of wrap if used: the test site was covered with a gauze-lined semi-occlusive dressing, which was fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes; with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw
- Concentration (if solution):undiluted

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: mortality; daily; a.m. and p.m. on working days, a.m. on weekend days, clinical signs of toxicity; daily
- Frequency of weighing: on days 1, 7, and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred

Clinical signs:

other: - Dyspnoea: starting 1 hour after dosing and lasting 5 days - Exophthalmoses: present 1 hour and 3 hours after dosing only - Ruffled fur: from 1 hour until day 9 after dossing - Abnormal body positions: ventral position (1 hour until day 1 after dosing) a

Gross pathology:

No deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met