Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-01-20 to 2009-01-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
, 2004
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
date of inspection 2008-08-19

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Physical state: solid, whitish to white crystals
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.48 to 2.68 kg
- Housing: individually housed in suspended cages.
- Diet (ad libitum): 2030 Teklad Global Rabbit diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Relative humidity: 30 to 70 %
- Air exchanges: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material, moistened with vehicle

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water
Duration of treatment / exposure:
4 hours
Observation period:
Approximately 1 hour as well as 24, 48 and 72 hours after patch removal
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: shaved epidermis on the dorsal/flank area
- Type of wrap used: 2.5 cm x 2.5 cm cotton gauze patch secured in position with a strip of surgical adhesive tape. The trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: Four hours after application
- Washing: any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM: according to the Draize scale
Any other skin reactions, if present, were also recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No evidence of skin irritation was noted during the study.
No corrosive effects were noted.
Other effects:
All animals showed expected gain in body weight during the study.

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 irritating to the skin based on an in vivo study (OECD 404). According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
Executive summary:

The skin irritation potential of the substance was investigated according to the OECD guideline 404. A single dose of 0.5 g of the substance moistened with distilled water was applied to the intact skin of three New Zealand White rabbits and covered semi-occlusive for an exposure period of 4 hours. The test sites were examined for skin reactions and scored according to the Draize scale after 1, 24, 48 and 72 hours. Signs of skin irritation or corrosion were not observed. According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classifiication as skin irritant.