2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 August 2009 to 20 October 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The Guidelines for the Testing of Chemicals Section 4: Health Effects (ministry of environmental protection of People's Republic of China).

Deviations:

no

GLP compliance:

not specified

Remarks:

Not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

EC Number:

946-937-7

Molecular formula:

C36H62N2O8

IUPAC Name:

2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

Test material form:

liquid

Details on test material:

- Storage: cool and dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adults
- Acclimation period: 5 days prior to the test

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24°C
- Humidity: 50 to 70%

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

4 animals

Details on study design:

TEST SITE
- Area of exposure: 2 x 3 cm^2 area on the scapular to lumbar region of the back.
- Type of wrap if used: The application sites were covered with two layers of polyethylene sheet, secured with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours, coverings were removed and the application sites were rinsed completely with warm water.

OBSERVATION TIME POINTS
Animals were observed continually for 14 days, Skin irritation was evaluated at approximately 1, 24, 48 and 72 hoursr after patches were removed from the sites. Animals were observed daily for mortality and signs of morbidity.

SCORING SYSTEM:
The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Remarks:

Max score not specified

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Remarks:

Max score not specified

Other effects:

Individual skin irritation scores are presented in Table 1. No abnormal clinical signs were observed during the whole study period. The mean skin irritation score was 0.

Any other information on results incl. tables

Table 1: Skin irritation scores

Animal No.	Position	Skin Irritation scores
		1 h		24 h		48 h		72 h
		R	L	R	L	R	L	R	L
1	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
2	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
3	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
4	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
Total		0	0	0	0	0	0	0	0
Mean		0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the test material was determined to be non-irritating to the skin.

Executive summary:

The skin irritation potential of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China). The test material was administered to a 2 x 3 cm² area on the scapular to lumbar region of the back that had been shaved on the previous day. The application sites were covered with two layers of polyethylene sheet, secured with adhesive tape. After 4 hours, coverings were removed and the application sites were rinsed completely with warm water. Animals were observed continually for 14 days. Skin irritation was evaluated at approximately 1, 24, 48 and 72 hours after patches were removed from the sites. Animals were observed daily for mortality and signs of morbidity. No abnormal clinical signs were observed during the whole study period. The mean skin irritation score was 0. Under the conditions of this study, the test material was considered to be non-irritating to the skin.