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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study (Draize test) with acceptable restrictions (occlusive dressing, intact and abraded skin test sites, TS substance preparation: 50%, 24 hours exposure duration, no details on test animals, only 24- and 72-hour scoring available, 72-hour observation period; TS purity not specified; non GLP)
Justification for type of information:
Category approach as part of CSR.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38 No. 187 § 1500.41
Deviations:
yes
Remarks:
48 h reading not performed
Principles of method if other than guideline:
Patch-test similar to the Draize test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: individually (after shaving to prevent injuries by bites) in V2A wire cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG, rabbit food; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum

No additional details provided

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or abraded (only data from the shaved skin sites are presented here, since they are suitable for assessment)
Vehicle:
other: The test material was prepared for application in polyethylene glycol (PEG; prepared as 7 parts PEG: 3 parts saline solution).
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): as 50% trituration in polyethylene glycol
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of the right flank (the whole back and flanks was shaved with an electric clipper 2 days before treatment). The shaven skin on the left side was slightly scarified immediately before treatment.
- % coverage: the patch was covered with a plastic film (5 cm x 5 cm))
- Type of wrap if used: the plastic film was fixed to the body with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: the gauze patches were removed 24 hours after the application

SCORING SYSTEM: comparable to the OECD scoring system (only 24- and 72-hour scores were determined)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Mean of all tested animals
Time point:
other: 24-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 48-hour scoring not performed
Irritation parameter:
edema score
Basis:
mean
Remarks:
Mean of all tested animals
Time point:
other: 24-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 48-hour scoring not performed
Irritant / corrosive response data:
No irritation was observed, neither on intact skin sites nor on the abraded ones. It could therefore be assumed that the test substance is not irritating according to EU-CLP.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU