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Toxicological information

Skin irritation / corrosion

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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:
other: The study was performed according to OECD guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
1.88
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
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)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean values 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 C&L the substance is classified as irritant because of the scaling observed from day 7 onwards.
Executive summary:

A sample of 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 a mild skin irritant.