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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:
2013-05-21 to 2013-05-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Description: clear colourless liquid
Expiry date: 29 June 2013
Storage conditions: room temperature, in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.26-2.33 kg
- Housing: Animals were individually housed in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 2013-05-21 To: 2013-05-24

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Test item was used as supplied (undiluted)
- pH of the undiluted test item: 6.0
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
Immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, the sites were examined for evidence of primary irritation.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: On the day of the test a suitable site was selected on the back of each rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch.
- Type of wrap if used: Treatment site was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: Four hours after application the corset and patches were removed from animals and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 Hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Very slight erythema was noted at two treated skin sites 1 and 24 h after patch removal.
No evidence of skin irritation was noted at one treated skin site during the study.
Other effects:
All animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Table 7.3.1/1: Individual Skin Reactions

Skin Reaction

Observation Time

(following patch

removal)

Individual Scores – Rabbit Number and Sex

73197 Male

73198 Male

73199 Male

Erythema/Eschar

Formation

Immediately

0

0

0

1 h

0

1

1

24 h

0

1

1

48 h

0

0

0

72 h

0

0

0

Mean (24, 48 and 72 h)

0.0

0.3

0.3

Oedema

Formation

Immediately

0

0

0

1 h

0

0

0

24 h

0

0

0

48 h

0

0

0

72 h

0

0

0

Mean (24, 48 and 72 h)

0.0

0.0

0.0

Individual body weights and body weight change:

Rabbit Number

Individual body weight (kg)

Body weight change (kg)

Day 0

Day 3

73197

2.33

2.40

0.07

73198

2.27

2.29

0.02

73199

2.26

2.29

0.03

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Under the test conditions the substance is not classified as irritating to skin according to the criteria of CLP Regulation (EC) No. 1272/2008.
Executive summary:

Test Guidance

OECD guideline 404 and EC Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).

Method and materials

Three New Zealand White male rabbits were dermally exposed to 0.5 mL of the test material for 4 h under a semi-occlusive dressing. After removal of the residual test item, irritation was scored immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, according to Draize method.

Results

Very slight erythema was noted at two treated skin sites 1 and 24 h after patch removal. No evidence of skin irritation was noted at one treated skin site during the study. All animals showed expected gain in body weight during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.3, 0.3 for erythema and 0.0, 0.0, 0.0 for oedema score, respectively. The mean erythema and oedema scores at 24, 48 and 72 h were 0.22 and 0.0 respectively. The substance is not a skin irritant in male rabbits.

Conclusion

Under the test conditions the substance is not classified as irritating to skin according to CLP Regulation (EC) No. 1272/2008.