Alcohols, C9-11-branched

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:

other: Acceptable, well-documented study report equivalent or similar to OECD guideline 402: GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar 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:

Alcohols, C9-11-branched

EC Number:

271-360-6

EC Name:

Alcohols, C9-11-branched

Cas Number:

68551-08-6

Molecular formula:

CnH2n+1OH (n = 10 to 12)

IUPAC Name:

Branched alcohols, C10-12, C11 rich

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Age at study initiation: Approximately 13 weeks
- Weight at study initiation: Males ( 2.17 - 2.69 kg), Females (2.38 - 2.48 kg)
- Housing: Individual
- Diet (e.g. ad libitum): Purina certified rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system ad libitum
- Acclimation period: 15 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1987-7-21 To: 1987-8-4

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal surface from the shoulder region to the lumber region
- Type of wrap if used: gauze patch covered with a plastic sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water and paper towels
- Time after start of exposure: 24h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3160 mg/kg
- Concentration (if solution): Assumed to be 100%; density of 0.8578 g/ml
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

3160 mg/kg

No. of animals per sex per dose:

5 each Male/Female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 2 and 4 hours after dosing, and once per day thereafter for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The means and standard deviations for the body weights and body weight changes were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Mortality:

There were no animal deaths prior to study termination.

Clinical signs:

other: - Most frequently noticed: Nasal discharge, staining of the ano-genital area, and alopecia - Low Incidences: soft stool and small amount of stool, a single incidence of ocular discharge, food consumption decrease, emaciation, and animal vocalization

Gross pathology:

- Well-defined to moderate/severe erythema in all animals at 24h and well-defined to severe erythema in all animals on Day 3.
- Very slight to severe erythema in all animals on Days7 and 10.
- Day 14 (3 animals with very slight erythema, 4 animals with well-defined erythema, and 3 animals with severe erythema)
- Very slight edema was noted in all animals at 24h
- Edema scores increased on Day 3 when all animals showed very slight to moderate edema.
- Atonia and desquamation were noted for all animals during the study, leathery skin was noted for 8 animals, eschar was noted for 7, and fissuring was noted for 5.
- Necrosis was noted for 2 animals
- Single incidence of exfoliation and blanching

Other findings:

GROSS POSTMORTEM EXAMINATION
- Alopecia for 8 animals
- Red areas on the skin of the dose site for 1 animal
- Renal discoloration for 1 animal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 for isoundecanol is >3160 mg/kg.

Executive summary:

Isoundecanol was administered via an occluded dermal patch to 5 each of male and female rabbits at the limit dose of 3160 mg/kg for 24 hours.  Dermal evaluations occurred at 2 and 4 hours post patch removal and once daily thereafter for 14 days.  At the end of the study, no animals succumbed to the dose, the dermal LD50 >3160 mg/kg.