Alcohols, C7-9-iso-, C8-rich

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: pre-GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1960

Report date:

1960

Reference 2

Reference Type:

publication

Title:

Acute toxicity of a homologous series of branched chain primary alcohols

Author:

Scala RA and Burtis EG

Year:

1973

Bibliographic source:

Am Ind Hyg Assoc J 34:493-499

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C7-9-iso-, C8-rich

EC Number:

271-231-4

EC Name:

Alcohols, C7-9-iso-, C8-rich

Cas Number:

68526-83-0

Molecular formula:

CnH2n+1OH (n = 7 to 9)

IUPAC Name:

Branched alcohols, C7-9, C8 rich

Details on test material:

- Name of test material (as cited in study report): MRD-59-12
- Physical state: clear liquid with an unpleasant odor
- Analytical purity: considered to be 100%

Test animals

Species:

rabbit

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: by exposure group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: intact abdominal skin
- Type of wrap if used: gauze covered with a plastic sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sponged with Fuller's earth
- Time after start of exposure: 24 h

Duration of exposure:

24 H

Doses:

100, 316, 1000, 3160 ul/kg (83.2, 262, 832, 2629 mg/kg based on a density of 0.832 mg/cm3)

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1, 4, and 24 hours and daily thereafter for a total of 7 days

Statistics:

No data analyzed.

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 2 632 mg/kg bw

Mortality:

1 animal in the 3160 ul/kg exposure group died within 24 hours post patch removal. All other animals survived until the end of the observation period.

Clinical signs:

other: Within 4 hours of application, animals in the 3160 ul/kg exposure group exhibited signs of depressed physiologic function. All adverse observations were resolved within 2 days post exposure.

Gross pathology:

Gross autopsy performed in the animal which succumbed revealed congested kidneys and lungs. All other animals had unremarkable findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of isooctanol is >2632 mg/kg.

Executive summary:

In this study, rabbits were exposed to varying concentrations (100, 316, 1000, or 3160 ul/kg) of isooctanol via an occluded dermal patch for 24 hours. Observations were made at 1, 4, and 24 hours and daily thereafter for a total of 7 days. One animal in the highest dose group died within 24 hours of patch removal. All other animals survived. Within 4 hours of application, animals in the 3160 ul/kg exposure group exhibited signs of depressed physiologic function. All adverse observations were resolved within 2 days post exposure. It is concluded that the LD50 is greater than 3160 ul/kg (2632 mg/kg).