Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: 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: Comparable to guideline study with acceptable restrictions (occlusive treatment, 24 h exposure duration, solution with 50% test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive treatment, 24 h treatment period, 6 animals, 50% test solution, intact and scarified skin)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 66'031/A
- Physical state: solid (powder)
- Analytical purtiy: > 80%
- Lot/batch No.: Op. 1/81

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS GmBH, Med. Versuchstierzuchten KG, D-7964 Kisslegg.
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet: standard rabbit food NAFAG, No. 814 Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and one side slightly scarified
Vehicle:
other: polyethylene glycol (PEG 400) + Saline (70:30)
Controls:
other: not required, untreated site of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test material
- Concentration (if solution): 50%

VEHICLE
- Concentration (if solution): 50%
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
3 per sex
Details on study design:
TEST SITE
- Area of exposure: Back of animal
- % coverage: % not reported; gauze patch size = 2.5 x 2.5 cm
- Type of wrap if used: impermeable material (no further details)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM: Scoring was performed according to the Draize Scoring System.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of animal #1, #3 and #4
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of animal #1 and #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of animal #4, #5 and #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: intact skin
Other effects:
One animal died after 6 days. No symptoms had been observed previously.

Any other information on results incl. tables

Results intact skin:

Readings Animal Erythema Edema Additional findings
24 h 1 2 2  
2 2 1  
3 2 2  
4 1 0  
5 1 0  
6 0 0  
48 h 1 1 1  
2 1 1  
3 1 1  
4 1 0  
5 0 0  
6 0 0  
72 h 1 0 0  
2 1 0  
3 0 0  
4 1 0  
5 0 0  
6 0 0  
4 d 1 0 0  
2 1 0  
3 0 0  
4 0 0  
5 0 0  
6 0 0  
7 d 1 0 0  
2 0 0  
3 0 0  
4 - - dead
5 0 0  
6 0 0  
Mean 24 - 72 h 1 1.0 1.0  
2 1.3 0.7  
3 1.0 1.0  
4 1.0 0.0  
5 0.3 0.0  
6 0.0 0.0  
mean 0.8 0.4  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance caused slight skin irritation in rabbits, however, as the reactions were weak and thus below the threshold for classification and the conditions chosen were harsher than required by the actual guideline (24 h treatment, occlusive conditions) the test substance is considered non irritating.