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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:
1985-05-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
Please refer to principles of method if other than guideline
Principles of method if other than guideline:
Similar to OECD 404 (1981) and in compliance with GLP; 24 h application, reading time points 24 and 72 h post-application
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(2,2-dimethyl-3-hydroxypropyl)toluene
EC Number:
403-140-4
EC Name:
3-(2,2-dimethyl-3-hydroxypropyl)toluene
Cas Number:
103694-68-4
Molecular formula:
C12H18O
IUPAC Name:
2,2-dimethyl-3-(3-methylphenyl)propan-1-ol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: not specified
- Weight at study initiation: in average 3 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 2 °C
- Humidity: 50 - 60 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved only and shaved and scratched
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g or 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
8
Details on study design:
TEST SITE
- Area of exposure: back
- coverage: 2.5 x 2.5 cm
- Type of wrap used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

OBSERVATION TIME POINTS
24 h, 72 h and 7 days after application

SCORING SYSTEM:
- according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
erythema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
erythema score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritation parameter:
edema score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: scoring at 48 h was not performed
Irritant / corrosive response data:
No effects in regards to erythema or edema scores were observed in any of the 8 treated animals at 24 and 72 h after treatment. Neither at the shaved only nor on the shaved and scratched site.
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study the test item is not considered to be a skin irritant to rabbit skin.
Executive summary:

The test item was applied to the skin of 8 New Zealand white rabbits for 24 h under an occlusive dressing. Treatment sites of the animal´s backs were shaved or shaved and scratched before test item application. After 24 h the treated locations were evaluated for erythema and edema formation according to Draize scoring system. Another assessment was done 72 h after treatment. At none of the time points any adverse changes were noted in any of the animals. Edema as well as erythema scores were "0" for all animals at both time points. Thus, the test is considered to not cause skin irritation based on the results of this study.