Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

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:
Constituent
Details on test material:
YBC-34B-003//P001, Lot number 18197-D-5
Purity: 99 %

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
#1: 3 minutes 0,5 ml one animal
#2: 1 hour 0,5 ml three animals
#3: 4 hour 0,5 ml three animals
Observation period:
14 days
Number of animals:
three animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
F8931, F8941, F8962
Time point:
other: day 14
Score:
ca. 2.17
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: normal
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as irritating to skin.
Executive summary:

3 Minute exposure: There was no erythema or edema noted at 1 hour following patch removal.

1 hour exposure: Erythema was absent to barely perceptible at 1 hour following patch removal, barely perceptible at 24 hours. absent to barely perceptible at 48 hours, and absent to well defined at 72 hours. Erythema was absent by day 7 and 14. Edema was absent at 1 hour following patch removal and absent to barely perceptible at 24 hours. Edema was absent at 48 and 72 hours, and on days 7 and 14.

4 hour exposure: Erythema was barely perceptible at 1 hour following patch removal and barely perceptible to well defined at 24, 48, 72 hours. Erythema was absent on days 7 and 14. Edema was absent at 1 hour following patch removal, barely perceptible at 24 hours, and absent to barely perceptible at 48 and 72 hours. Edema was absent on days 7 and 14.

Systemic Observations: There were no abnormal physical signs noted during the observation period. All body weight changes were normal.