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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:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: about 2.5 kg
- Housing: individual cages
- Diet: laboratory standard diet for rabbits (Altromin/Lage)
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C ± 2 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL


Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not specified
- Type of wrap: adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1, 24, 48, 72 h, 7 days

SCORING SYSTEM:
- Method of calculation: Draize

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
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No indication of irritation after 1, 24, 48, 72 h or 7 days.
Other effects:
No indication to an incompatibility with the weight gains of untreated animals within the 7 days observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.
Executive summary:

A skin irritation test was performed according to OECD 404 and GLP. In the study 5 rabbits were exposed to 0.5 mL of the undiluted test substance for 4 hours. After removal of the test substance the test site (2.5 x 2.5 cm) was evaluated after 1, 24, 48, 72 hours and 7 days. The mean erythema and edema score for 24/48/72h and 7 days were 0. Due to these results the test substance was found to be not skin irritating and without classification at 100 %.