Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Principles of method if other than guideline:
0.5 mL of the undiluted test substance was applied on intact and abraded skin of 3 rabbits each for 24 h. The irritancy was scored 24 and 72 h after application of the test substance according to the Draize scoring system.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: approx. 90%
- Impurities (identity and concentrations): propylene glycol, 11%
- Lot/batch No.: 5850

Test animals

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 - 2.5 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded skin (Animals with abraded skin were not taken into account for assessment.)
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% (undiluted)

Duration of treatment / exposure:
24 h
Observation period:
72 h
Reading time points: 24 and 72 h after application
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: 6.542 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with water.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibilty: not applicable
Remarks on result:
other: intact skin
Irritant / corrosive response data:
In the conducted study, the test material did not induce any irritation to abraded or intact skin of rabits and is therefore considered as not irritant.

Applicant's summary and conclusion

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