bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993/04/01 to 1993/04/19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

Study conducted in compliance with agreed protocols, with minor deviations from standard test guidelines, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous substances Act (16 CFR 1500.41)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate

EC Number:

700-897-5

Molecular formula:

C40H76O4

IUPAC Name:

bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: rabbits were obtained from a suitably licensed dealer
- Age at study initiation: 3 months of age
- Housing:individually housed in stainless steel cages.
- Diet (e.g. ad libitum): Diet consisted of Big Red Rabbits Choice Rabbit Rood
- Water (e.g. ad libitum): ad libitum
- Weight at study initiation: 2kg
- Acclimation period: at least 4 days


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
- Temperature (oF): 65-75

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 (volume or weight with unit): 0.5 ml
- Concentration (if solution): tested as supplied

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm2
- Two sites: one is shaved and another one is abraded
- Type of wrap if used: the test article was then covered with 2.5x2.5 cm2 surgical gauge pad and a Kendal Webril pad. The latter was held in place with 3 inch hypo-allergenic cloth tape. After both test sites were treated, the entire trunk of each animal was encased in an impermeable plastic occlusive wrapping fixed in place with 3 inch porous tape. This aided in maintaining the test article and patcheds in position and prevented the evaporation of possible volatile components of the test article.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Patch wiped free with water ana paper towels
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

1.35

Max. score:

8

Remarks on result:

probability of mild irritation

Any other information on results incl. tables

The Dermal Irritation Scores in Individual Rabbits

RABBIT NUMBER	SKIN	24h		72h
		ER	ED	ER	ED
1	Intact	2	1	0	0
2	Intact	2	1	0	0
3	Intact	2	0	1	0
4	Intact	2	1	0	0
5	Intact	2	0	0	0
6	Intact	2	0	0	0
1	Abraded	2	1	0	0
2	Abraded	2	1	0	0
3	Abraded	2	0	1	0
4	Abraded	2	1	0	0
5	Abraded	2	0	0	0
6	Abraded	2	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not a skin irritant.

Executive summary:

Test Guidance

Skin irritation study performed according to method of Federal Hazardous Substances Act (16 CFR 1500).

 

Method and Material

Six New Zealand White rabbits were shaved and a 0.5 mL portion of the test material was applied to an intact or abraded skin site. The test article was then covered with 2.5x2.5 cm²surgical gauge pad and a Kendal Webril pad. The latter was held in place with 3 inch hypo-allergenic cloth tape. After both test sites were treated, the entire trunk of each animal was encased in an impermeable plastic occlusive wrapping fixed in place with 3 inch porous tape. This aided in maintaining the test article and patches in position and prevented the evaporation of possible volatile components of the test article. 

The wrapping was removed after 24 hours and washed from the skin with water and paper towels. Treated areas were examined for erythema and oedema using the Draize method of scoring at 24 and 72 hours.

Results

The neat (100%) test material induced erythema scores of 2 (6/6 animals) and 1 (3/6 animals) at 24 and 72 hour respectively; and oedema score of 1 (3/6 animals) at 24 hour observations. Edemal was fully reversible within 72 hours, and there was evidence of reversibility for erythema over the limited timeframe of the study.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin corrosion/irritation.