Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD guideline 404 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.0 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg of the compound were applied and covered with gauze patches in a size of about 2.5 cm x 2.5 cm.
This was wettened with 10 mL warmed water.
Duration of treatment / exposure:
4 h
Observation period:
The treated areas of the animals were examined 1 hour after patch removal. Thereafter, the readings have been repeated every 24 hours. The final control of localization has been carried out after 7 days.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches were fixed with the help of adhesive plaster


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was touched away with a wet towel
- Time after start of exposure: 1 h


SCORING SYSTEM:
1. Erythema and formation of scabs:
- No erythema: 0
- slight erythema (scarcely visible): 1
- Moderate to significant erythema: 3
- Severe erythema (red purple) with formation of slight scabs (deep lesions): 4

2. Formation of oedema:
- No oedema: 0
- Very slight oedema (scarcely visible): 1
- Slight oedema (well defined outlines, swelling apparent): 2
- Moderate oedema (thickness about 1 mm): 3
- Severe oedema (thickness more than 1 mm and area larger than of the square): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritant / corrosive response data:
No deviations from the normal findings have been observed during the whole experiment on any animal on the shave skin localizations.
Other effects:
No test-substance related findings were observed during the weighting of the animals after 7 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As no skin reaction was induced over a period of 7 days, the test item is considered as not skin irritating. Based on these results and according to the EC criteria for classification and labelling according to DSD (Directive 67/548/EEC) or GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

As no skin reaction was induced over a period of 7 days in a GLP study acc. to OECD guideline no. 404, test item is considered as not skin irritating.