Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NEB654 COND
- Physical state: colourless liquid
- Lot/batch No.: A13 04 A0022
- Expiration date of the lot/batch: December 2013
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
3 female albino New Zealand rabbits
weight 2.16 - 3.04 kg
11 weekd old

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Dose of 0.5 ml
Duration of treatment / exposure:
4 hrs
Number of animals:
3
Details on study design:
The untreated opposite flank of the animal was served as the control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hrs
Score:
1.667
Max. score:
2
Reversibility:
fully reversible within: 7 and 14
Remarks on result:
other: slight to well defined
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hrs
Score:
2
Max. score:
2
Reversibility:
fully reversible within: days 3 and 7
Remarks on result:
other: slight edema
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hrs
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hrs
Score:
1.667
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hrs
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hrs
Score:
0.667
Max. score:
1
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained enable to conclude that the test item must be classified "irritating to skin, according Dir. 67/548, 2001/59 and 99/45.
In accordance with the Reg. no. 1272/2008/EC the test item must not be classified.