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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:
20 March 2006 to 23 March 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The skin irritation potential of three batches of the test material was assessed in the rabbit.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Appearance: Light yellow liquid, Clear Liquid
- Stability: There was no apparent change in the physical state of the test material during administration
- Storage conditions of test material: Room temperature, protected from exposure to light

Test animals

Species:
rabbit
Strain:
other: JW

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male animals were exposed to three batches of test material
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was removed with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM
The Draize scoring system was used. Reactions were assessed 1, 24, 48 and 72 hours after test material application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
score of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
score of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
At the 24, 48 and 72 hour time points, no rabbit showed any reaction to the test material with regard to erythema and oedema formation. All scores were 0.

Any other information on results incl. tables

Table 1: Summary of Scores for the First Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

101

Erythema

0

0

0

0

Oedema

0

0

0

0

102

Erythema

0

0

0

0

Oedema

0

0

0

0

103

Erythema

1

0

0

0

Oedema

0

0

0

0

 

Table 2: Summary of Scores for the Second Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

101

Erythema

0

0

0

0

Oedema

0

0

0

0

102

Erythema

0

0

0

0

Oedema

0

0

0

0

103

Erythema

1

0

0

0

Oedema

0

0

0

0

 

Table 3: Summary of Scores for the Third Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

101

Erythema

0

0

0

0

Oedema

0

0

0

0

102

Erythema

0

0

0

0

Oedema

0

0

0

0

103

Erythema

1

0

0

0

Oedema

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions this study, the test material is not classified as a dermal irritant in accordance with EU criteria.
Executive summary:

A study was conducted to assess the potential of the test material to cause irritation to the skin of rabbits using methodology similar to that outlined in the standardised guideline OECD 404.

The skin irritation potential of three batches of the test material was assessed in 3 male JW rabbits. The dose level administered was 0.5 mL/2.5 x 2.5 cm site. Observations were made at 1 hour after exposure and then every 24 hours for a total duration of 72 hours. The Draize scoring system was used to determine the degree of skin reaction.

At the 24, 48 and 72 hour time points, no rabbit showed any reaction to the test material with regard to erythema and oedema formation. All scores were 0.

Under the conditions this study, the test material is not classified as a dermal irritant in accordance with EU criteria.