reaction mass of [(1R*,5S*)-3,3,5-trimethylcyclohexyl] acetate and [(1S*,5S*)-3,3,5-trimethylcyclohexyl] acetate

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in Apr 2002

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 12 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 12 days

Results 4

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.