Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. Reliability reduced to take account of read across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500.41
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
- Name of test material (as cited in study report): Sample No. 910-77

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace animals, Inc., Boyertown, PA, USA
- Age at study initiation: 'young adult'
- Weight at study initiation: 2.31-2.68 kg
- Housing: individually housed in wire mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and then abraded on one side
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 31 %
Duration of treatment / exposure:
24 h
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch square
- % coverage: no data
- Type of wrap if used: gauze patch and Blenderm tape then wrapped in occlusive binder.

REMOVAL OF TEST SUBSTANCE
- Washing : gently wiped with a clean gauze
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 24.5 h post dose
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 72 h post dose
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: slight eschar formation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals -abraded skin
Time point:
other: 24.5 h post dose
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals - abraded skin
Time point:
other: 72 h post dose
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: slight eschar formation
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 24.5 h post dose
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - intact skin
Time point:
other: 72 h post dose
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - abraded skin
Time point:
other: 24.5 h post dose
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals - abraded skin
Time point:
other: 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU