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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
Study period:
not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: 59 NohSan No. 4200
Version / remarks:
1985
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
other: Japanese white female rabbits
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation:15 weeks old
- Weight at study initiation: 2.50 to 2.71 kg
- Housing: animals were housed individually in aluminium cages with wire mesh bottoms
- Diet: RC4 pellet diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 50 ± 20
- Air changes: at 8 to 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: Start: 20 Oct. 1995; End: 31 May 1996

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
10 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2 lint (6.3 cm2)
- % coverage: not specified
- Type of wrap if used: The application site was covered with oil-paper followed by the semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed after the exposure period and the skin was wiped with absorbent cotton soaked in ‘water for injection’ to clean the application site so that any reactions (erythema) were clearly visible at that time
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours and 7 and 10 days after patch removal

SCORING SYSTEM:
Method of calculation: the skin was scored according to the OECD scoring system (see Table 1 in 'any other information on materials and methods incl. tables'). Mean values of scores from 24-48-72 hours per animal were taken for the classification. The interpretation of the results is based on table 2 in 'any other information on materials and methods incl. tables'.

CLINICAL SIGNS
Clinical signs were observed periodically for 6 hours after application and then once daily thereafter at the same time as dermal observation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
With a single application of the test substance to the rabbit skin, no irritant dermal reactions were observed and the primary dermal irritation index was zero.
Other effects:
No abnormalities in the clinical signs any of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
With a single application of the test substance to the rabbit skin, no irritant dermal reactions were observed.
Executive summary:

In a primary dermal irritation study, six 13 week old Japanese white female rabbits were dermally exposed to 0.5 g of the test substance (98.6%) for 4 hours to the previously clipped skin of the rabbits dorsal area. Animals then were observed for up to 72 hours after removal of the test material. Irritation was scored by a table for evaluation of dermal reactions. Based on the results and under the conditions of this study, it was concluded that the test substance has no irritant effect on the rabbit skin according to the Draize classification criteria.