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Diss Factsheets

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

Constituent 1
Chemical structure
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.