Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 404: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C9-11-iso-, C10-rich
EC Number:
271-234-0
EC Name:
Alcohols, C9-11-iso-, C10-rich
Cas Number:
68526-85-2
Molecular formula:
CnH2n+1OH (n = 9 to 11)
IUPAC Name:
Alcohols, C9-11-iso-, C10-rich
Details on test material:
- Name of test material (as cited in study report): MRD-91-127
- Physical state: Liquid
- Analytical purity: Assumed to be 100%
- Lot/batch No.: 1
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products
- Age at study initiation: Approximately 13 weeks
- Weight at study initiation: 1.96-2.30 kg
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): neat
Duration of treatment / exposure:
4 hours
Observation period:
45 minutes, 24, 48 and 72 hours and Day 7
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal surface from the shoulder region to the lumbar region
- Type of wrap if used: gauze patch secured with tape loosely held in contact with the skin by means of a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material removed after 4 hours; water and paper towel
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: sustained response
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.56
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: sustained response
Irritation parameter:
erythema score
Basis:
animal: JEI664M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI664M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI664M
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI670M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI670M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI670M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI648M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI648M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI648M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI665M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI665M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI665M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI667M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI667M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI667M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI680M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI680M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEI680M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI664M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI664M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI664M
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI670M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI670M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI670M
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI648M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI648M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI648M
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI665M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI665M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI665M
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI667M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI667M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI667M
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI680M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI680M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEI680M
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
-Topical application elicited very slight erythema in 5 animals at the 45 minute interval
- Erythema increased after the 45 minute interval and at the 24 and 48 hours interval, 2 animals were noted with well-defined erythema and 4 animals were noted with very slight erythema.
- Erythema increased again at the 72 hour and Day 7 intervals; 5 animals were noted with well-defined erythema and 1 animal with very slight.
-Desquamation was noted in 4 animals at the Day 7 interval while exfoliation was noted in 2 animals at the Day 7 interval.
Other effects:
All animals survived the study

Any other information on results incl. tables

Individual animal dermal scores:

Animal ID     45 minutes   24 hours   48 hours   72 hours   7 days
 JEI664M Erythema   1  1  1  1  2
 

Edema

 1  0  1  1  1
 JEI670M  Erythema  1  1  1  2  2
   Edema  0  0  1  1
 JEI648M  Erythema  0  1  2  2  2
   Edema  0  0  1  1  1
 JEI665M  Erythema  1  1  1  2  1
   Edema  0  0  0  1  0
 JEI667M  Erythema  1  2  2  2  2
   Edema  0  1  1  1  0
 JEI680M  Erythema  1  2  1  2  2
   Edema  0  1  0  0  2

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Branched alcohols, C9-C11, C10-rich is a skin irritant.
Executive summary:

Isodecanol was administered via an occluded patch to 6 rabbits at a dose of 0.5 ml for 4 hours of exposure to assess dermal irritation.  Observations were conducted at 45 minutes, 24, 48 and 72 hours and 7 days after exposure.  Well defined erythema was noted in 1 animal at the 45 minute point while the other animals had very slight erythema. Erythema increased after the 45 minute interval. Five animals were noted with well-defined erythema at the 24 and 48 hour intervals; the mean primary dermal irritation index was 2.16. At the 72 hour interval, all animals were noted with well-defined erythema. Erythema increased again at the Day 7 interval; two animals were noted with severe erythema and four animals were noted with well-defined erythema.  The mean skin irritation scores between 24 and 72 hours were: erythema 1.5 and edema 0.56. Four of six animals exhibited desquamation at Day 7, and the other two animals exhibited exfoliation at Day 7.