Reaction mass of 1-methyl-4-(1-methylethylidene)cyclohexyl acetate and p-menth-1-en-8-yl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Reliability 2 is assigned because it is a GLP compliant study conducted in compliance with OECD guideline 404 but observations were not followed until the reversibility of the effects (only 7 days).

Justification for type of information:

An in vivo study was conducted prior to the introduction of the regulatory requirement for an in vitro study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No details on test animals and environmental conditions; no details on patch material; observations not followed until the reversibility of the effects (only until days 7)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-menth-1-en-8-yl acetate

EC Number:

201-265-7

EC Name:

p-menth-1-en-8-yl acetate

Cas Number:

80-26-2

Molecular formula:

C12H20O2

IUPAC Name:

1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

other: albino

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

Test 1: 3
Test 2&3: 4

Details on study design:

SCORING SYSTEM: Draize scoring system
- tested in a multi-patch study

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.89

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Test 1

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Test 1

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Test 2

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Test 2

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.75

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Test 3

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Test 3

Irritant / corrosive response data:

Test 1: One animal showed marked desquamation at the 7 day time interval. The other two animal showed desquamation at the 7 day time interval.
Test 2: One animal showed desquamation at the 7 day time interval. One other animal showed slight desquamation at the 7 day time interval.
Test 3: One animal showed minimal desquamation at the 7 day time interval. The other three other animals showed slight desquamation at the 7 day time interval.

Any other information on results incl. tables

 Test 1

	1 hr	1 day	2 days	3 days	7 days	Mean (24, 48, 72 hrs)
Animal No. 1
Erythema	0	1	2	2	1	1.67
Oedema	0	1	1	1	1	1
Animal No. 2
Erythema	2	2	2	2	1	2
Oedema	1	2	2	2	1	2
Animal No. 3
Erythema	1	2	2	2	2	2
Oedema	2	2	2	2	1	2

 

Test 2

	1 hr	1 day	2 days	3 days	7 days	Mean (24, 48, 72 hrs)
Animal No. 1
Erythema	2	2	2	2	2	2
Oedema	3	3	3	3	1	3
Animal No. 2
Erythema	2	2	2	2	1	2
Oedema	2	2	2	2	1	2
Animal No. 3
Erythema	2	2	2	2	1	2
Oedema	2	2	2	2	1	2
Animal No. 4
Erythema	1	2	2	2	1	2
Oedema	0	2	2	2	1	2

 

Test 3

	1 hr	1 day	2 days	3 days	7 days	Mean (24, 48, 72 hrs)
Animal No. 1
Erythema	2	2	2	2	1	2
Oedema	1	2	2	2	1	2
Animal No. 2
Erythema	1	2	2	1	1	1.67
Oedema	1	2	1	0	0	1
Animal No. 3
Erythema	1	2	2	2	1	2
Oedema	1	1	1	0	0	0.67
Animal No. 4
Erythema	1	2	1	1	0	1.33
Oedema	0	1	0	0	0	0.33

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

in accordance with EU CLP (EC no. 1272/2008 and its updates)

Conclusions:

Terpinyl acetate alpha does not cause skin irritation in the primary dermal irritation studies (OECD TG 404).

Executive summary:

In three primary dermal irritation studies performed according to OECD TG 404 and in compliance with GLP, three or four albino rabbits were dermally exposed to 0.5 mL of undiluted alpha-Terpinyl Acetate under a semi-occlusive patch for 4 hours to intact skin of the flank. Animals were then observed for 7 days. Irritation was scored by the method of Draize at 1, 24, 48 and 72 hours and 7 days after exposure.

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals of the first test were 1.66, 2 and 2 for erythema score and 1, 2 and 2 for edema score. For the second test 2, 2, 2 and 2 for erythema score and 3, 2, 2 and 2 for edema score. For the third test the mean individual scores were 2, 1.67, 2 and 1.33 for erythema score and 2, 1, 0.67 and 0.33 for oedema score.

Under the test conditions Terpinyl acetate alpha is considered to be not irritating to the skin.