2-tert-butylcyclohexyl ethyl carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 October 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline 404 without deviation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-tert-butylcyclohexyl ethyl carbonate

EC Number:

267-184-4

EC Name:

2-tert-butylcyclohexyl ethyl carbonate

Cas Number:

67801-64-3

Molecular formula:

C13H24O3

IUPAC Name:

2-tert-butylcyclohexyl ethyl carbonate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): SAT 940563
- Physical state: Colourless liquid
- Storage condition of test material: Room temperature
- Other: pH: 6.17 (1 % aqueous emulsion, measured by pH-meter).

Specific details on test material used for the study:

- Stability under test conditions: Stable under conditions of storage until 30 June, 1995.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97633 Sulzfeld.
- Weight at study initiation: 2.4-2.8 kg
- Housing: Animals were housed individually in metal wire cages.
- Diet: Altromin 2023 diet for rabbits, ad libitum.
- Water: Tap water, acidified to pH 3.0, from an automatical watering system, ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: average of 19 °C
- Humidity: average of 60 %
- Air changes: 12 per hour
- Photoperiod: 12 h dark / 12 h light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 h & 6 days after patch removal

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: Test site was median on the dorsal thoracal region.
- Type of wrap if used: A cellulose patch (Pur-Zellin, Hartmann AG, 5cm x 4 cm) with 0.5 mL of the test substance, spread over an area of approximately 6 cm2, was applied to the test site and held in place by fixing marginally with non irritating tape (Blenderm Wundpflaster, 3M). The application site was covered by a dressing (Fixomull Stretch, Fa. Beiersdorf). Access by the animal to the application site was prevented by a plastic collar.

At the end of the exposure period the dressing, the tape with the patch and the collar were removed.

REMOVAL OF TEST SUBSTANCE
- Residual test substance was wiped off using wet cellulose tissue.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to OECD Guideline 404

OTHER:
The skin was examined using a cold light source KL 1500 electronic.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

- All areas treated with the test substance were normal before application. The control areas were normal at each observation time.
Examinations 1 h after patch removal:
- Erythema/eschar: Very slight erythema (score "1" each) was observed in 2/3 animals (animal No.1071 and 1073), well-defined erythema (score "2") in the third animal (animal No.1072).
- Oedema: Slight oedema (score "2" each) was noted in 2/3 animals (animal No.1071 and 1073) and moderate oedema (score "3") in the third animal (animal No.1072).
Reading times (24, 48 and 72 h after patch removal):
- Erythema/eschar: In all animals very slight erythema (score "1" each) was observed at each reading time.
- Oedema: In animal No.1071 slight oedema (score "2") was noted 24 h, very slight oedema (score "1") 48 h, a score of "0" 72 h after the end of exposure; In animal No.1072 slight oedema was found 24 and 48 h, very slight oedema 72 h after patch removal; In animal No.1073 very slight oedema was observed 24 h after patch removal, scores of "0" at the other reading times.
- Additional observation times (6 days after patch removal):
In all animals additional examinations were performed 6 days after the end of exposure and scores were "0".

Other effects:

No general toxic effects of the test substance were observed.

Any other information on results incl. tables

Table 7.3.1/1: Scores of the application sites

 

Time after the end of exposure	Erythema / Eschar formation   animal No.			Oedema formation   animal No.
	1071	1072	1073	1071	1072	1073
1 h	1	2	1	2	3	2
24 h	1	1	1	2	2	1
48 h	1	1	1	1	2	0
72 h	1	1	1	0	1	0
Mean (24, 48 and 72 h)	1.0	1.0	1.0	1.0	1.7	0.3
6 days	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, test item "SAT 940563" is not classified according to the criteria of Annex VI to the Regulation (EC) N°1272-2008 (CLP) and to the GHS.

Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three female New Zealand White rabbits were dermally exposed to 0.5 mL of test item "SAT 940563" under a semi-occlusive dressing for 4 h. After removal of the residual test item, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 & 72 h and 6 days after exposure.

Examinations 1 h after patch removal: Very slight erythema (score "1" each) was observed in 2/3 animals, well-defined erythema (score "2") in the third animal. Slight oedema (score "2" each) was noted in 2/3 animals and moderate oedema (score "3") in the third animal.

Reading times (24, 48 and 72 h after patch removal): In all animals very slight erythema (score "1" each) was observed at each reading time. In 1/3 animals slight oedema (score "2") was noted 24 h, very slight oedema (score "1") 48 h, a score of "0" 72 h after the end of exposure. In another animal slight oedema was found 24 and 48 h, very slight oedema 72 h after patch removal. In the third animal very slight oedema was observed 24 h after patch removal, scores of "0" at the other reading times. No lesions were observed on Day 6 after the exposure.

 

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1.0, 1.0, 1.0 for erythema and 1.0, 1.7, 0.3 for oedema score, respectively.

 

Under the test conditions, test item "SAT 940563" is not classified according to the criteria of Annex VI to the Regulation (EC) N°1272-2008 (CLP) and to the GHS.