Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No date
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
This information is not provided in the migrated NONS file provided by ECHA.

Test animals

Species:
rabbit
Strain:
other: New Zealand hybrid albino rabbit
Details on test animals or test system and environmental conditions:
This information is not provided in the migrated NONS file provided by ECHA.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: This information is not provided in the migrated NONS file provided by ECHA.
Vehicle:
other: Sterile codex liquid paraffin
Controls:
other: This information is not provided in the migrated NONS file provided by ECHA.
Amount / concentration applied:
46 mg/l (no other information provided in the migrated NONS file provided by ECHA).
Duration of treatment / exposure:
4h
Observation period:
This information is not provided in the migrated NONS file provided by ECHA.
Number of animals:
6
Details on study design:
This information is not provided in the migrated NONS file provided by ECHA.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: observation period
Remarks on result:
other: Maximum duration : 48d. Maximum value at the end of observation period : 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Maximum duration: 0 d. Maximum value at the end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: changes fully reversible within 3 days.
Other effects:
This information is not provided in the migrated NONS file provided by ECHA.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] has been determined not to be a dermal irritant to rabbit skin.
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule.

The skin irritation has been determined according to the OECD Guideline 404 and the EU Method B.4, and in compliance with GLP.

The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] has been determined not to be a dermal irritant to rabbit skin. It is not classified for skin irritation according to the criteria of DSD and CLP.