α-methylcyclohexylmethyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

See at justification for type of information

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-03-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is considered to be a reliability 2 since it predates GLP but is similar to OECD TG 404.

Justification for type of information:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available [study scientifically not necessary / other information available]

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

α-methylcyclohexylmethyl acetate

EC Number:

236-798-4

EC Name:

α-methylcyclohexylmethyl acetate

Cas Number:

13487-27-9

Molecular formula:

C10H18O2

IUPAC Name:

α-methylcyclohexylmethyl acetate

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated skin of each animal served as controls.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

6 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
24 hours after the application.

OBSERVATIONS
The skin reactions were assessed at approximately 4, 24, 48, 72 and 168 hours after exposure to the test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404 (1981)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours (mean)

Score:

1.55

Max. score:

4

Reversibility:

fully reversible

Remarks:

within 7 days

Remarks on result:

other: average scores 24h, 48h and 72h were 1.67, 1.50, and 1.50, respectively

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours (mean)

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: average scores 24h, 48h and 72h were 1.00, 0, and 0, respectively

Other effects:

Defatting effect, skin sloughed off in ten to fourteen days. There was no injury in depth.

Any other information on results incl. tables

Skin irritation response data (for the undiluted test substance)

	Time after administration
	4 hour						24 hours						48 hours						72 hours
Animal	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6
Erythema	1	1	1	1	1	1	2	2	2	2	1	1	2	1	2	2	1	1	2	1	2	2	1	1
Edema	0	0	0	0	0	0	1	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

According to CLP Regulation (EC) 1272/2008

Conclusions:

In a skin irritation study with rabbits, performed similar to OECD 404 (1981), mild irritation was observed, which was fully reversible within 7 days. Based on the results of this study, the substance is considered to be not irritating to skin for CLP. The substance also does not need to be classified according to GHS because only 3/6 animals reached score 2 over 24, 48 and 72hours, while for classification 4/6 animals should have > 2 erythema or oedema score.

Executive summary:

The substance was tested a in a skin irritation test similar to the OECD TG 404 test guideline. 6 New Zealand White rabbits were exposed for 24 hours to the undiluted test substance. The mean value for erythema from gradings at 24, 48 and 72 hours after patch removal was 1.55. For edema, this mean value was 0.33. No corrosive effects were observed. The irritation was fully reversible within 7 days. The substance is not considered to be irritating to skin, according to EU CLP criteria.