1,1,3,3-tetramethylbutyl peroxyneodecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 May 1986 - 21 May 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,3,3-tetramethylbutyl peroxyneodecanoate

EC Number:

257-077-0

EC Name:

1,1,3,3-tetramethylbutyl peroxyneodecanoate

Cas Number:

51240-95-0

Molecular formula:

C18H36O3

IUPAC Name:

2,4,4-trimethylpentan-2-yl 2,2,3,5-tetramethylhexaneperoxoate; 2,4,4-trimethylpentan-2-yl 2,2-diethylhexaneperoxoate; 2,4,4-trimethylpentan-2-yl 2,2-dimethyloctaneperoxoate; 2,4,4-trimethylpentan-2-yl 2,4-dimethyl-2-(propan-2-yl)pentaneperoxoate; 2,4,4-trimethylpentan-2-yl 2-ethyl-2,5-dimethylhexaneperoxoate

Details on test material:

- Chemical name: Neodecane peroxoic acid 1,1,3,3-tetramethyl butyl ester
- Appearance: Colouless clear liquid
- CAS-reg. no.: 51240-95-0

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands.
- Age at study initiation: animal 260: 09-12-1985, 8 to 10 weeks old; animal 295: 12-03-1986, 8 to 10 weeks old; animal 450: 10-04-1986, 12 to 14 weeks old.
- Weight at study initiation: see above
- Housing: They were individually housed in plastic cages with perforated floors.
- Diet (e.g. ad libitum):ad libitum, standard laboratory animal diet (100 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm)
- Water (e.g. ad libitum):ad libitum
- Acclimation period:7-days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 60-85
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 06 May 1986 - 21 May 1986

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral flank

Amount / concentration applied:

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

During dose administration the test substance was kept on ice.

Duration of treatment / exposure:

4 hours

Observation period:

The exposed skin areas were examined for signs of erythema and oedema and the responses were scored at 60 minutes, and approximately 24, 48 and 72 hours, and 7 and 14 days after removal of the patch. For reference the control site on the contralateral flank was used. In order to facilitate the scoring, the skin area concerned of animals no. 450 was shaved again before the observations on day 14.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6cm2
- % coverage: -
- Type of wrap if used: 6 cm2 gauze patch, which was attached with a drop of petrolatum to al uminium foil and mounted on permeable tape (Micropore, 3M, St. Paul, USA). This was applied to the right flank of each animal, the left flank being covered with the same dressing without testsubstance. Finally, the animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue moistened with tap-water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Scoring system Erythema and oedema
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight edema(barely perceptible) 1
Slight edema(edges of the area well defined by definite raising) 2
Moderate edema(raised approximately 1mm) 3
Severe edema( raised more than 1 mm and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.88

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.44

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

The skin of the animals showed very slight oedema, persisting for 24 to 48 hours, and moderate erythema. In one of the animals (no. 260) the redness was still present 7 days after dosing, while the skin of animal 295 showed well-defined erythema for 3 days. In case of animal 450 the adverse skin effects had disappeared on day 3. Scale formation was observed on the treated skin area of all animals from day 7 onwards. Signs of systemic intoxication were not observed in any of the rabbits.

Other effects:

None

Any other information on results incl. tables

no.	Effect	Hour	Days after application					Mean score erythema 24/48/72 h	Mean score oedema 24/48/72 h
		1	1	2	3	7	14
1	Erythema/ eschar Oedema	2   2	2   1	2   1	2   0	2   0	0   0	2	0.67
2	Erythema/ eschar Oedema	1   1	3   1	2   0	2   0	0   0	0   0	2.33	0.33
3	Erythema/ eschar Oedema	1   1	3   1	1   0	0   0	0   0	0   0	1.33	0.33

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The mean value for eshar/erythema is =>1.5 and =< 2.3 for 2 out of 3 animals. The oedema score is < 1.5. Although the scoring does not warrant classification, the substance is classified as irritant because of the scaling observed from day 7 onwards.

Executive summary:

A sample of the test substance was tested in the rabbit primary skin irritation/corrosion test to determine its possible irritating or corrosive effects.

The flank skin of 3 female rabbits was exposed to 0.5 ml of the test substance for 4 hours using semi-occlusive dressing. This resulted in very slight, temporary oedema, and moderate erythema, which persisted for seven days in one animal and for two to three days in the other animals. The treated skin area of all animals showed scale formation from day 7 onwards. Based on the scores that were obtained the substance is considered a mild skin irritant.