Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles. Conducted prior to implementation of OECD and GLP guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guideline (§ 1500.41, Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
no
GLP compliance:
no
Remarks:
conducted prior to GLP guideline implementation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG breeding colony
- Strain: SPF-Albino-Himalayan, Hoe HIMK(SPFWiga)
- Weight at study initiation: 1,5 - 2,5 kg
- Housing: single cage
- Diet: ERKA 8300, ad libitum
- Water: tap water, ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact and clipped scarified
Vehicle:
other: 0.9% NaCl aqueous solution
Controls:
not required
Amount / concentration applied:
0.5 g mixed with 0.5 ml 0.9% NaCl aqueous solution
Duration of treatment / exposure:
24h
Observation period:
72 h after beginning of treatment
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #30
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant because of lacking effects
Remarks on result:
other: clipped intact
Irritation parameter:
erythema score
Basis:
animal: #36
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h after beginning of treatment
Remarks on result:
other: clipped intact
Irritation parameter:
erythema score
Basis:
animal: #37
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h after beginning of treatment
Remarks on result:
other: clipped intact
Irritation parameter:
erythema score
Basis:
animal: #38
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h after beginning of treatment (end of observation), but expected to be reversible within a prolonged observation period of 14 days.
Remarks on result:
other: clipped intact
Irritation parameter:
erythema score
Basis:
animal: #39
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h after beginning of treatment
Remarks on result:
other: clipped intact
Irritation parameter:
erythema score
Basis:
animal: #40
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h after beginning of treatment (end of observation), but expected to be reversible within a prolonged observation period of 14 days. Due to bad quality of the document the unreadable 72h score value was extrapolated by expert judgement.
Remarks on result:
other: clipped intact
Irritation parameter:
edema score
Basis:
animal: #30
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h after beginning of treatment
Remarks on result:
other: clipped intact
Irritation parameter:
edema score
Basis:
animal: #36 - #39 each
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant because of lacking effects
Remarks on result:
other: clipped intact
Irritation parameter:
edema score
Basis:
animal: #40
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h after beginning of treatment. Due to bad quality of the document the unreadable 72h score value was extrapolated by expert judgement.
Remarks on result:
other: clipped intact
Irritant / corrosive response data:
Based on the slightness and the full recovery in the majority of test animals a full reversibility of effects within 2 weeks is expected for the remaining ones.

Similar score values were obtained for clipped scarified skin.

Single animals showed temporarily scaled or chapped skin. Two animals formed scab which was not fully reversible within the observation period of 72 h. These effects were not assigned to the intact or scarified skin by the author of the report, but are assumed to be most likely associated with the scarified skin.
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the test results the substance does not meet criteria for classification concerning skin cxorrosion/irritation as laid down in Regulation (EC) No 1272/2008.

This conclusion is legitimated even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill endpoint requirements.
Executive summary:

The test material was tested for skin irritancy according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance mixe with 0.5 ml of 0.9% NaCl aqueous solution for 24 h under occlusive conditions and the skin responses were examined at 24, 48, and 72 h after beginning of treatment. Mean values of the 24, 48 and 72 h readings were calculated for each animal. Only slight effects (erythema mean score: <=1, edema mean score: <= 0.3) below the threshold for classification were determined for the intact skin. All effects were fully reversible or expected to be fully reversible. Similar results were obtained for scarified skin. Based on these findings the test material was judged not to be irritating or corrosive to skin.