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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
pH not evaluated, observation after 30-60 min not conducted; Exposure conditions were more intesive than required by the OECD guideline 404 , in respect of duration and coverage. Each animal was treated at clipped intact as well as abraded skin sites.
Principles of method if other than guideline:
Exposure conditions were more intensive than required by OECD Guideline 404 such that appliction duration was 24 hours hours instead of 4 hours under, type of coverage was occlusive instead of semiocclusive and each of 6 animals was treated at clipped intact as well as abraded skin sites.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
- Appearance: light yellow flakes
- Molecular weight: 136.1
- Density: 1.04 g/cm³ (112 °C)
- Flash point: 147 °C
- Boiling point: 263 °C
- Melting point: 111.7 °C
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: pulverisation with mortar, moistened with distilled water

Test animals

Species:
rabbit
Strain:
other: Kbs:JW
Remarks:
japanese white rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Weight at study initiation: 2.1 - 2.5 kg
- Diet (ad libitum): solid feed RC-4 (obtained from Oriental Yeast K.K)
- Water ( ad libitum): tap water
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 55 ± 6 %

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped, partly left intact, partly abraded (stratum corneum was removed with injection needles)
Vehicle:
other: distilled water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per application site, clipped intact as well as abraded skin areas were treated at each animal.
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6 male animals
Details on study design:
TEST SITE
- Area of exposure: within a circle of 3 cm (according to 7 cm²)
- Type of wrap if used: two layers of gauze patch fixed in a closed patch with Tegaderm (3M) and Ju Picot 5 (obtained from Tokyo Material Research Institute)

REMOVAL OF TEST SUBSTANCE
- removal with gauze soaked in water

OBSERVATION TIME POINTS
- daily after application period. Reported values for 24, 48, 72 and 168 hours

SCORING SYSTEM:
- Method of calculation: scoring of erythema and edema was conducted according to Draize method after 24, 48, 72 and 168 hours.
(Please refer to the field 'Any other information on materials and methods incl. tables')

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin; 24 hour occlusive exposure
Other effects:
no effects observed

Any other information on results incl. tables

Table 1: Results

Items

Erythema

Oedema

Observation time

24

72

24

72

Rabbit No.

 

 

 

 

1 int

0

0

0

0

Abr

0

0

0

0

2 int

0

0

0

0

Abr

0

0

0

0

3 int

0

0

0

0

Abr

1

0

0

0

4 int

1

0

0

0

Abr

1

0

0

0

5 int

0

0

0

0

Abr

0

0

0

0

6 int

0

0

0

0

abr

0

0

0

0

Int: intact skin

Abr: abraded skin

1 out of 6 rabbits displayed at the intact site and 2 out of 6 rabbits displayed at the abraded skin sites mild erythema (Draize score 1) after 24 hours, which was reversible after 48 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is non-irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.