Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
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)
Deviations:
no
GLP compliance:
yes

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-91-126
- Physical state: liquid, colorless

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: 2.08-2.33 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- 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
Duration of treatment / exposure:
4 h
Observation period:
45 minutes, 24, 48 and 72 hours and Day 7 post patch removal
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap if used: semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water and paper towels
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Draize scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
1.89
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
1.22
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Day 7
Score:
2.67
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Day 7
Score:
1.5
Irritation parameter:
erythema score
Basis:
animal: JEI678M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI678M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI678M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI642M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI642M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI642M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI645M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI645M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI645M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI675M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI675M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI675M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI672M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI672M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI672M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI641M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI641M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: JEI641M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI678M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI678M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI678M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI642M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI642M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI642M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI645M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI645M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI645M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI675M
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI675M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI675M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI672M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI672M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI672M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI641M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI641M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: JEI641M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
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. 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.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
While the quantitative threshold for mean erythema and/or edema at 24, 48, and 72 hours were not met, skin irritation was not completely reversible by the end of the observation period.
Executive summary:

Topical application of isooctanol produced only signs of mild irritation in the rabbit following a 4 hour semi-occluded dermal patch exposure. Dermal observations were conducted 45 minutes, 24, 48 and 72 hours and 7 days after exposure. All animals survived the 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. 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 1.89 and edema 1.22.