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: Acceptable well documented report which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 21
Author:
OECD
Year:
2007
Bibliographic source:
OECD SIDS

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
In deviation of modern guidelines occlusive patches were used in this study, representing exaggerated exposure conditions.
Principles of method if other than guideline:
The procedure used is based, but not in every part identical with the proposed guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study". Federal Register, Vol 43 No. 163, August 22, 1978.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 65'023/L
- Physical state: powder
- Analytical purity: active substance content 83%,
- Lot/batch No.: EN 20
- Stability under test conditions: not determined

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
adraded skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Erythema score after 24, 48 and 72 h (animal1/2/3/4/5/6)

 Exposure time  24 h  48 h  72 h  
 intact skin  2/2/2/2/1/1   2/2/2/2/1/1  1/2/1/1/0/0
 abraded skin  2/1/0/2/1/1   1/1/0/2/1/1  1/0/0/0/0/0

Edema score after 24, 48 and 72 h (animal1/2/3/4/5/6)

 Exposure time  24 h  48 h  72 h
intact skin  1/2/1/0/0/0  1/1/1/0/0/0 0/1/0/0/0/0
abraded skin  1/1/0/1/0/0  1/0/0/0/0/0 1/0/0/0/0/0

All effects were fully reversible within 7 days (all scores: 0.0). There was no staining of the treated skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritant to skin.