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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
animals used: female rats; application every 2nd day within an experimental period of 12 days
GLP compliance:
yes

Test material

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

Test animals

Species:
rat
Strain:
other:
Remarks:
Alderley Park SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd.m Margate, UK
- Age at study initiation: ca. 1 month
- Weight at study initiation: ca. 150 g
- Fasting period before study: 16 - 20 h before dosing
- Housing: steel cages, 50 x 30 x 18 cm
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: >= 7d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 60% r.h.
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg mixed with water to a paste
Duration of treatment / exposure:
24 h (six applications on days 0, 2, 4, 6, 8)
Observation period:
12 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 1 x 1 inch
- Type of wrap if used: gauze, rubberised cloth

REMOVAL OF TEST SUBSTANCE
- Wahsing with 1% centrimide solution
- Time after start of exposure: 24 h (corresponding to days 1, 3, 5, 7, 9)

OBSERVATION TIME POINTS
daily (days 0 - 12)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: day 12
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: day 12
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation occured at any time
Other effects:
staining of skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not induce any signs of irritation on rat skin within the experimental period of 12 days. During this period, every 24 h, 100 mg of the test substance were occlusively applied to clipped rat skin. The other days, the substance was removed and the skin was examined for any signs of irritation. No signs were found at any time. Therefore, the substance is classifiable as irritant according to the CLP Regulation.