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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Acute Toxicity to the rat
Author:
SCALA et al.
Year:
1973
Bibliographic source:
American Industrial Hygiene Association Journal

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The dermal irritation study of the test chemical was conducted on clipped and intact abdominal skin of albino rabbits.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):Tridecanol (C-13)
- Molecular formula :C13H28O
- Molecular weight :200.37 g/mole
- Substance type:Solid
- Physical state:Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report):Tridecanol (C-13)
- Molecular formula :C13H28O
- Molecular weight :200.37 g/mole
- Substance type:Solid
- Physical state:Organic

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals and environmental conditions:
- Housing: The animals were housed individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and intact abdominal skin
Vehicle:
unchanged (no vehicle)
Remarks:
No data
Controls:
yes
Amount / concentration applied:
0.1 ml of undiluted test chemical
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
4
Details on study design:
TEST SITE
Area of exposure: closely clipped, intact abdominal skin
% coverage: No data
Type of wrap if used: Occlusive binding of dental damming

REMOVAL OF TEST SUBSTANCE
Washing (if done): After the exposure, the binding was removed, and the remaining material, if any, was cleaned from the skin
Time after start of exposure: 24 hours

SCORING SYSTEM:
Grading scale is slight-moderate-marked and severe

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
The chemical caused persistent atonia and desquamation with some necrosis or eschar.
Other effects:
Part of the irritation seen was associated with trapping of liquid under the occlusive binder at a point where the binder was bound to the animal. These areas of intimate contact and pressure gave rise to some of the reported necrosis and eschar. Dermal irritation for tridecyl alcohol showed good dose relations for intensity and duration.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The findings reveled persistent atonia and desquamation with some necrosis or eschar. Part of the irritation seen was associated with trapping of liquid under the occlusive binder at a point where the binder was bound to the animal. These areas of intimate contact and pressure gave rise to some of the reported necrosis and eschar.Also the chemical showed good dose relations for intensity and duration.
Therefore, the test chemical was considered as moderately irritating to the clipped and intact abdominal skin of albino rabbits.
Executive summary:

The dermal irritation study of the test chemical was conducted on clipped and intact abdominal skin of albino rabbits.

 

The test chemical was applied full-strength to the closely clipped, intact abdominal skin of albino rabbits in groups of four. The exposed area was covered with an occlusive binding of dental damming for 24 hours. After the exposure, the binding was removed, and the remaining material, if any, was cleaned from the skin. The animals were housed individually with feed and water freely available. No mechanical restraints were used.

 

Observations for dermal irritation were made on a daily basis. Gross necropsies were performed at the end of the experiments.Grading scale was slight-moderate-marked and severe.

 

The findings reveled persistent atonia and desquamation with some necrosis or eschar. Part of the irritation seen was associated with trapping of liquid under the occlusive binder at a point where the binder was bound to the animal. These areas of intimate contact and pressure gave rise to some of the reported necrosis and eschar.Also the chemical showed good dose relations for intensity and duration.

Therefore, the test chemical was considered as moderately irritating to the clipped and intact abdominal skin of albino rabbits.