Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study to Guideline 84/449/EWG,B.4 by GLP compliant laboratory

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: moistened with Tween 80
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
4 hrs
Observation period:
24, 48 &72 hrs
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM: Erythem score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24.48.72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not classified
Executive summary:

Due to the lack of information provided by ECHA, it is difficult to assess this end point fully. It appears from information provided that the substance has low irritation.