Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1960
Report date:
1960
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

Constituent 1
Chemical structure
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:
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).