Octane-1-thiol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-01-05 to 1981-01-27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was classified as reliable with restrictions because it was well-documented and followed OECD Guideline 402 with some exceptions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

occlusive wrapping used; only one exposure dose was used and it was below the recommended limit dose

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octane-1-thiol (CAS # 111-88-6)

IUPAC Name:

Octane-1-thiol (CAS # 111-88-6)

Details on test material:

- Name of test material (as cited in study report): Phillips n-octyl mercaptan (Octane-1-thiol)
- Substance type: Heavy Mercaptan

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: University of Utah Vivarium
- Age at study initiation: young adult
- Weight at study initiation: 2 to 3 Kg
- Housing: Individually in galvanized or stainless steel cages with screen floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70°F ± 3°F
- Humidity (%): 30% to 60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1981-01-05 To: 1981-01-27

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: sidesection
- Type of wrap if used: occlusive plastic sheet

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess sopnged off lightly
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/Kg or 2 g moistened in saline (if solid)

Duration of exposure:

24 hours

Doses:

2 ml/kg (1680 mg/kg)

No. of animals per sex per dose:

3

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily for first 3 days and then daily thereafter; Body weight - prior to dosing and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 680 mg/kg bw

Remarks on result:

other: 1680 mg/kg = 2 mL/kg

Mortality:

No mortality was observed in either male or female rabbits through the study period.

Clinical signs:

other: All animals exhibited erythema, five of six rabbits also developed induration and did not return to normal.

Gross pathology:

All tissues appeared normal at necroscopy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information mortality was not noted but the dose level was below the recommended dose for a limit test Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study, groups of New Zealand albino rabbits (3/sex) were dermally exposed to octane-1-thiol for 24 hours at a dose of 1680 mg/kg bw. Animals then were observed for 14 days. The dermal LD50 was determined to be >1680 mg/kg bw in males and females.

Executive summary:

In an acute dermal toxicity study, groups of New Zealand albino rabbits (3/sex) were dermally exposed to octane-1-thiol for 24 hours at a dose of 1680 mg/kg bw. Animals then were observed for 14 days.

 

No mortality occurred. No treatment related clinical signs, necropsy findings, or body weight. The dermal LD₅₀ was determined to be >1680 mg/kg bw in males and females.

 

This study was classified as a supporting study because of the dose selection. This study received a Klimisch score of 2 and was classified as reliable with restrictions because it was well-documented and followed OECD Guideline 402 with some exceptions.