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Diss Factsheets

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
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C9-11-branched and linear
EC Number:
288-284-4
EC Name:
Alcohols, C9-11-branched and linear
Cas Number:
85711-26-8
Molecular formula:
C9H20O, C10H22O and C11H24O
IUPAC Name:
Alcohols, C9-11-branched and linear
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Camm Research Institute, New Jersey, USA
- Age at study initiation:
- Weight at study initiation: 2.2 - 3 kg
- Housing: individual, suspended, stainless steel cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 21 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
24 hour(s)
Observation period:
24 and 48 hours after exposure and at 7 days.
Number of animals:
3M, 3F
Details on study design:
TEST SITE
- Type of wrap if used: gauze patches were held in place with strips of Blenderm tape. The entire trunk was then covered in plastic covering, which was secured and sealed and then wrapped with elastic bandage to immobilize and occlude the patches.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was wiped away with a moist towel.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Remarks on result:
other: intact skin
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.46
Max. score:
4
Remarks on result:
other: intact skin
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Remarks on result:
positive indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.25
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
skin reactions were assessed at 24/72h
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: Mean 24 + 72 hour score for 6 animals intact skin 2.67,  abraded skin 2.75.
- Oedema: Mean 24 + 72 hour score for 6 animals intact skin 1.46, abraded  skin 1.54.
-PDII 4.2

REVERSIBILITY: At 7 days all the application sites had developed eschar  (scored as 4) so the effects had increased over the period of the study.  
PII 4.2.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The in vivo skin irritation study for Alcohols, C9-11-branched and linear, conducted according to a protocol similar to OECD Test Guideline 404 and in compliance with GLP, concluded Alcohols, C9-11-branched and linear to be irritating to skin.