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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:
weight of evidence
Study period:
15 - 18 Jan 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: 6 New Zealand albino rabbits were exposed dermally under occlusive conditions to the undiluted test substance for 24 h. The test substance was applied to abraded and non-abraded skin sites. The skin was observed for erythema and edema (Draize scoring system) 1 and 48 h after removal of the test substance.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Nottingham, UK
- Weight at study initiation: 2.59 - 3.35 kg (range: males and females)
- Housing: individually in suspended metal cages
- Diet: rabbit diet (John Waring (Feeds) Limited, Shardlow, Derbyshire, UK), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Air changes (per hr): at least 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Remarks:
test site on right flank of the animals
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:
24 h
Observation period:
48 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test substance was introduced under a composite patch which consisted of a 2.5 cm square of absorbent lint B.P.C. backed by a 2.5 cm square of polythene with a final backing of a 4 cm square of lint. The patch was held in position by two lengths of sleek adhesive strapping in the form of a cross.

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gentle swabbing the test site with cotton wool soaked in lukewarm water.
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
1 and 48 h after removal of the patches


SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #3
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #4, #5 and #6
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not apllicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Intact skin:
At the 1-h reading time point, very slight erythema (score 1) was observed in 1/6 animals. The erythema had cleared completely within 48 hours after patch removal. No oedema was observed in any animal at any time reading time point.

Abraded skin:
Very slight erythema (score 1) was observed in 2/6 animals 1 h after patch removal. All evidence of irritation had disappeared 48 h after patch removal.



Any other information on results incl. tables

Table 1. Results of irritation test on intact and abraded skin sites 1h and 48 h after patch removal

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Intact skin

1 h

0

0

0

0

1

0

0

0

0

0

0

0

48 h

0

0

0

0

0

0

0

0

0

0

0

0

Abraded skin

1 h

0

0

1

0

1

0

0

0

0

0

0

0

48 h

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: Study can not be used for classification
Conclusions:
The result of the in vivo skin irritation study is not conclusive with respect to non-classification or classification as a skin irritant and therefore requires further evaluation and/or data generation.