[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 9 to 12, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

No data on test animals and environmental conditions, 24 h exposure period, occlusive dressing used, observation at 24 and 72 h only, complete reversibility not observed.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 1500.41-Federal Hazardous Substances Act Regulations-16 CFR- P.124.

Deviations:

not specified

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol

EC Number:

943-328-8

Molecular formula:

Not applicable

IUPAC Name:

Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): MT-112

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one side intact, the other side abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Side of the animals
- Type of wrap if used: Treated areas were covered with gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize method.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean 24 and 72h

Score:

1.5

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Mean 24 and 72h

Score:

1

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: Mean 24 and 72h

Score:

2

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Mean 24 and 72h

Score:

1

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: Mean 24 and 72h

Score:

1.5

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Mean 24 and 72h

Score:

1

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: Mean 24 and 72h

Score:

1.5

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: Mean 24 and 72h

Score:

1

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: Mean 24 and 72h

Score:

1.5

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: Mean 24 and 72 h

Score:

1

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 11

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: Mean 24 and 72 h

Score:

1.5

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: Mean 24 and 72 h

Score:

1

Max. score:

4

Reversibility:

other: No data

Remarks on result:

other: Intact skin

Irritant / corrosive response data:

- Very slight to well defined erythema and very slight oedema were observed.

Other effects:

No data

Any other information on results incl. tables

Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test (intact skin)

 

Score at time point / Reversibility	Erythema Max. score 4	Oedema Max. score 4
24 h	1 / 2 / 1 / 1 / 1 / 1	1 / 1 / 1 / 1 / 1 / 1
72 h	2 / 2 / 2 / 2 / 2 / 2	1 / 1 / 1 / 1 / 1 / 1
Average 24h, 72h	1.5 / 2 / 1.5 / 1.5 / 1.5 / 1.5	1 / 1 / 1 / 1 / 1 / 1
Reversibility*)	nc.	nc.
Average time for reversion	-	-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Table 7.3.1/2: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test (abraded skin)

 

Score at time point / Reversibility	Erythema Max. score 4	Oedema Max. score 4
24 h	1 / 2 / 1 / 2 / 1 / 2	1 / 1 / 1 / 1 / 1 / 1
72 h	2 / 2 / 2 / 2 / 2 / 2	1 / 1 / 1 / 1 / 1 / 1
Average 24h, 72h	1.5 / 2 / 1.5 / 2 / 1.5 / 2	1 / 1 / 1 / 1 / 1 / 1
Reversibility*)	nc.	nc.
Average time for reversion	-	-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Under the test conditions, the test material is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and is classified "Mild skin irritant Cat.3" according to the GHS.

Executive summary:

In a dermal irritation study, 0.5 g of undiluted test material was dermally applied on the intact or abraded side surface of 6 albino rabbits. Test sites were covered with an occlusive dressing for 24 h. These deviations from OECD Test Guideline No. 404 were noted: the exposure period was 24 hours instead of 4 hours, occlusive dressing was used instead of semi-occlusive dressing, and the animals were observed for 3 days instead of 14 days although complete reversibility was not achieved. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch. Under the test conditions, the test material induced very slight to well defined erythema (Mean 24 -72 h = 1.5 / 2 / 1.5 / 1.5 / 1.5 /1.5) and very slight oedema (Mean 24 -72 h = 1 / 1 / 1 / 1 / 1 / 1).  According to these scores, the test material is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and is classified "Mild skin irritant Cat.3" according to the GHS.