Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study following a method equivalent to a recognised OECD guideline. Deviations to recognised guideline are noted.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Occlusive dressing smaller exposure area (ca. 2.5cm2), longer exposure period (24h) shorter observation period (48h)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41

Deviations:

no

Principles of method if other than guideline:

The method was in accordance with the 16 CFR 1500.41 and US CPSC requirements

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

EC Number:

248-792-9

EC Name:

Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Cas Number:

28043-10-9

Molecular formula:

C11H18O2

IUPAC Name:

methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Test material form:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

other: albino; not otherwise specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Not reported.
- Weight at study initiation: Not reported.
- Housing: Not reported but in compliance with Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3 (USA).
- Diet: rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: Not reported.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped / abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): neat (liquid)

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 (sexes not specified)

Details on study design:

TEST SITE
- Area of exposure: According to 16 CFR 1500.41
- % coverage: Not reported. A group of six albino rabbits was clipped over a wide area. One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.
- Type of wrap if used: Occlusive (gauze wrapped with impervious material)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: Not applicable.

SCORING SYSTEM: Draize-scoring system. References: 16 CFR 1500.41 and 16 CFR 1500.3.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: mean of 24 and 72 h

Score:

0

Max. score:

8

Remarks on result:

other: intact and abraded skin

Irritant / corrosive response data:

Intact skin: No edema and no erythema responses were observed in any animal at any observation point.

Any other information on results incl. tables

Table 1. Skin reactions (using Draize scoring method)

Erythema & Eschar Formation	Hours	Rabbit number						Mean score
		1	2	3	4	5	6
Intact skin	24	0	0	0	0	0	0	0.00
	72	0	0	0	0	0	0	0.00
Abraded skin	24	0	0	0	0	0	0	0.00
	72	0	0	0	0	0	0	0.00
Edema
Intact skin	24	0	0	0	0	0	0	0.00
	72	0	0	0	0	0	0	0.00
Abraded skin	24	0	0	0	0	0	0	0.00
	72	0	0	0	0	0	0	0.00
Sum of mean scores								0.00
Primary irritation index = sum of mean scores/4								0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US FDA

Conclusions:

Under the conditions of this study the test substance is not considered to be irritating to the skin.

Executive summary:

The GLP study was completed under 16 CFR 1500.41 following a guideline similar to OECD 404, to assess the irritancy potential of the test material to the skin of the albino rabbit. The test substance was evaluated in 6 albino rabbits. A dose of 0.5 ml test substance was applied to intact and abraded clipped dorsal skin site under a occlusive dressing for 24 hours. Skin observations were made 24 and 72 hours after patch removal. No edema or erythema responses were noted (Score = 0) at 24 or 72 hours in the intact and/or the abraded skin in all organisms. The test material produced a mean primary irritation index (PII) of 0.00 and is considered to be non-irritating to skin.