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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in Apr 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004/73/EC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Behörde für Arbeit, Gesundheit und Soziales, Hamburg, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
reaction mass of [(1R*,5S*)-3,3,5-trimethylcyclohexyl] acetate and [(1S*,5S*)-3,3,5-trimethylcyclohexyl] acetate
EC Number:
946-282-7
Molecular formula:
C11H20O2
IUPAC Name:
reaction mass of [(1R*,5S*)-3,3,5-trimethylcyclohexyl] acetate and [(1S*,5S*)-3,3,5-trimethylcyclohexyl] acetate

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 5.5 - 6.5 months
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: animals were kept singly in cages (400 mm x 500 mm x 370 mm) before and after exposure, singly in restrainers during exposure
- Diet: ssniff K-H V233 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
14 days
Reading time points: 1, 24, 48 and 72 h and 4 to 14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap: The treated skin was covered with a gauze patch, which was held in place with a non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 12 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 12 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
An erythema (grade 1) was observed in animal #1 and #2 from 24 h to 11 and 13 days, respectively, after patch removal. An erythema (grade 1) was observed in animal #3 from 1 h to 11 days after patch removal.
Other effects:
Induration of the skin was observed in animal #1 7 to 9 days after patch removal.
There were no systemic intolerance reactions.

Any other information on results incl. tables

Table 1. Results of the skin irritation study.

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

0

0

0

0

1

0

24 h

1

0

1

0

1

0

48 h

1

0

1

0

1

0

72 h

1

0

1

0

1

0

Mean value
24 + 48 + 72 h

1.00

0

1.00

0

1.00

0

4 days

1

0

1

0

1

0

5 days

1

0

1

0

1

0

6 days

1

0

1

0

1

0

7 days

1

0#

1

0

1

0

8 days

1

0#

1

0

1

0

9 days

1

0#

1

0

1

0

10 days

1

0

1

0

1

0

11 days

1

0

1

0

1

0

12 days

0

0

1

0

0

0

13 days

-

-

1

0

 -

14 days

-

-

0

0

 -

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.
Executive summary:

The skin irritation potential of the test substance was determined by an in vivo skin irritation test in rabbits according to OECD Guideline 404 and in compliance with GLP (2004). A dose of 0.5 mL of the test substance was applied to the skin of three rabbits under semi-occlusive conditions for 4 hours. After the exposure period the patch was removed and the skin sites were evaluated. Scores were taken 60 minutes, 24, 48, 72 hours and 4 to 14 days after patch removal. An erythema (grade 1) was observed in two animals (no. 1 and 2) from 24 h to 11 and 13 days, respectively, after patch removal. An erythema (grade 1) was observed in animal no. 3 from 1 h to 11 days after patch removal. In addition, induration of the skin was observed in animal no. 1 from Day 7 to 9. No systemic intolerance reactions were observed. Based on the results, the test substance was not irritating to the skin under the conditions of the test.