Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
See at justification for type of information
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977-03-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is considered to be a reliability 2 since it predates GLP but is similar to OECD TG 404.
Justification for type of information:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available [study scientifically not necessary / other information available]

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated skin of each animal served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
24 hours after the application.

OBSERVATIONS
The skin reactions were assessed at approximately 4, 24, 48, 72 and 168 hours after exposure to the test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404 (1981)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours (mean)
Score:
1.55
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 7 days
Remarks on result:
other: average scores 24h, 48h and 72h were 1.67, 1.50, and 1.50, respectively
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours (mean)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: average scores 24h, 48h and 72h were 1.00, 0, and 0, respectively
Other effects:
Defatting effect, skin sloughed off in ten to fourteen days. There was no injury in depth.

Any other information on results incl. tables

Skin irritation response data (for the undiluted test substance)

 

Time after administration

 

4 hour

24 hours

48 hours

72 hours

Animal

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

Erythema

1

1

1

1

1

1

2

2

2

2

1

1

2

1

2

2

1

1

2

1

2

2

1

1

Edema

0

0

0

0

0

0

1

1

1

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
According to CLP Regulation (EC) 1272/2008
Conclusions:
In a skin irritation study with rabbits, performed similar to OECD 404 (1981), mild irritation was observed, which was fully reversible within 7 days. Based on the results of this study, the substance is considered to be not irritating to skin for CLP. The substance also does not need to be classified according to GHS because only 3/6 animals reached score 2 over 24, 48 and 72hours, while for classification 4/6 animals should have > 2 erythema or oedema score.
Executive summary:

The substance was tested a in a skin irritation test similar to the OECD TG 404 test guideline. 6 New Zealand White rabbits were exposed for 24 hours to the undiluted test substance. The mean value for erythema from gradings at 24, 48 and 72 hours after patch removal was 1.55. For edema, this mean value was 0.33. No corrosive effects were observed. The irritation was fully reversible within 7 days. The substance is not considered to be irritating to skin, according to EU CLP criteria.