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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The primary dermal irritation of the test substance was examined in guinea pigs.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Purity: not reported

In vitro test system

Vehicle:
physiological saline

Test animals

Species:
guinea pig
Strain:
Hartley
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC, Inc. (3371-8 Koto-cho, Harnamatsu-shi, Shizuoka, Japan)
- Age at study initiation: 6 weeks
- Weight at study initiation: not reported
- Housing: Aluminum cages (W 350 mm x D 400 mm x H 230 mm). Animals were kept in groups of 5 or 6 per cage during the quarantine period and in groups of 5 per cage during the study period.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2°C
- Humidity (%): 50±10%
- Air changes (per hr): 17 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours/dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

VEHICLE
- Amount(s) applied (volume or weight with unit): physiological saline

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): physiological saline

POSITIVE CONTROL: No
Duration of treatment / exposure:
24 hours
Observation period:
3, 24, and 48 hours after patch removal
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: lateral abdomen (normal and abraded skin)
- % coverage: not reported
- Type of wrap if used: non-permeable adhesive plaster and elastic adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
OBSERVATION TIME POINTS: 3, 24, and 48 hours

SCORING SYSTEM:
- Method of calculation: Draize scale

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
8
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reaction was observed at any observation time in either the normal skin or abraded skin similarly to the control group.
Other effects:
No abnormality was observed in general conditions dnring the stndy period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No irritation was observed.
Executive summary:

Skin irritability of the test substance was examined using five albino Hartley guinea pigs. Normal and abraded skin regions were provided on the shaven lateral abdomen of each animal. The pure test substance as a white powder was used in the study with dropping physiological saline on it in order to improve contact with the skin. For administration, 0.1 g of the test substance was placed on the cloth portion of the adhesive plaster for patch test with a drop of physiological saline on it and applied as a 24-hour closed patch using an adhesive sponge plaster and elastic plaster. Irritation reactions were observed at 3, 24 and 48 hours after removal of the patch in accordance with the Draize’s assessment criteria. As a result, no abnormality was observed in general conditions during the study period. No skin reaction was observed at any observation time in either the normal skin or abraded skin similarly to the control group, and the primary irritation index (P.I.I.) was 0.