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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:
from 20th of May to 12th of June, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
other: colorless fluid

Test animals

Species:
rabbit
Strain:
other: SPF Albino Rabbits

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
after 4 h of exposure, the tape and patches were removed and the treated skin was cleaned with lukewarm water.
Observation period:
The skin reactions were read 1 h after the patches removal. reading was also made 24, 48 and 72 h after termination of exposure. Also 7, 14 and 21 days after
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #1
Time point:
other: 1h after patch removal
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #2
Time point:
other: 1h after patch removal
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #3
Time point:
other: 1h after patch removal
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
Erythema-Eschar
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h after patch removal
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h after patch removal
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1h after patch removal
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In view of the results obtained, the test item is considered to be irritant , based on the criteria set out in directive 2001/59/EC, Annex VI, and it is therefore assigned the risk phrase R38. According to CLP Regulation (EC No 1272/2008) and the Globally Harmonized System of Classification and Labeling of Chemicals /GHS) the test item has to be classified as Category 2 (irritant) and assigned the risk phrase H315 .
Executive summary:

The test substance SAT 960 266 (CAS number 28219 -60 -5) was assessed on its skin irritation potential according to test method described in the OECD Guidelines nº 404 (1992) and EEC Guideline B.4 (1992).

As a results, after 24 hours in all rabbits a moderate erythema and a slight oedema was seen, and after 48 and 72 h, a moderate to severe erythema and a moderate oedema was observed in all the rabbits.

On day 7 all test areas of all animaks were covered with scales. Animal No 824 showed a slight swelling of test areas. 

On day 14 test areas of animal No. 824 were completely covered with scales, those of animal No. 822 were covered at 80%. Left test area of animal No. 803 was covered at 75%, right test area was covered at 30%.

On day 21, none of the animals showed skin reactions

The mean individual erythema scores were 2,67 for all three animals

The mean individual oedema scores were 1,67 for all three animals

The conclusion is that the test item is considered to be irritant based on the criteria set out in DSD/DPD regulation and it is therefore assigned the risk phrase R38. According to CLP regulation and the GHS criteria the test item has to be classified as Category 2 (irritant) and assigned the risk phrase H315.