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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study (OECD TG 404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
RALOX 46, batch number: 95041

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
3 (2 males, 1 female)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
6
Reversibility:
other: no effcts
Remarks on result:
other: no effects

Any other information on results incl. tables

Very slight erythema (grad 1) was noted at one treated skin site at the 1-hour observation. No dermal reactions were noted at the 24, 48 and 72 -hours observations.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive according to EU labeling regulations

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, RALOX 46, produced a primary irritation of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effcts were noted.
Executive summary:

The test material, RALOX 46, produced a primary irritation of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effcts were noted.

The test material did not meet the critera for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.