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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:
29 April 1987 - 6 May 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study is performed under GLP and according to OECD 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

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:
Description: amber-coloured liquid
Container: glass screw-top bottle
Sponsor's identification : AMPHOLAK X00-30P
Date of arrival : 15 April 1987
Storage conditions : room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K. and Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.40 -3.12 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 55-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 29 April 1987 - 6 May 1987

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage: no data
- Type of wrap if used: A quantity of 0.5ml of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed i n position on the shorn skin. The patch was secured i n position over the test material with a strip of surgical adhesive tape (BLENDERN: approximate size 25 m x 40 mm). To prevent the animals from interfering w i t h the patches the trunk of each I rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours

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

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0.53
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritant / corrosive response data:
Very slight erythema was noted at all test sites one hour after removal of the wrapping and at the 24-hour observation but persisted at only one test site at the 48 and 72-hour observations. Very slight oedema was noted at all test sites one hour after removal of the wrapping but at only one test site at the 24-hour observation. All test sites appeared normal on day seven.

Any other information on results incl. tables

Summary of dermal lesions (following 4-h application)

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

31

Erythema/ eschar

Oedema

1

1

1

0

0

0

0

0

0

0

0.3

0.0

68

Erythema/ eschar

Oedema

1

1

1

0

0

0

0

0

0

0

0.3

0.0

90

Erythema/ eschar

Oedema

1

1

1

0

1

0

1

0

0

0

1.0

0.0

Mean

0.53

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material was found to be non-i rritant to rabbit skin according to GHS.
Executive summary:

A skin irritation/corrosion study was carried out in order to assess the irritancy potential of a test material following a single 4-hour, semi-occluded application to the intact rabbit skin. The study was designed to comply with the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" and was performed under GLP. Very slight erythema was noted at all test sites one hour after removal of the wrapping and at the 24-hour observation but persisted at only one test site at the 48 and 72-hour observations. Very slight oedema was noted at all test sites one hour after removal of the wrapping but at only one test site at the 24-hour observation. All test sites appeared normal on day seven. The test material was found to be non-i rritant to rabbit skin according to GHS.