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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Purity: 99.6%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age: 3-5 months
- Weight : 1.8-2.2 kg
- Housing: Air-conditioned areas in single cages (battery system)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits, ad libitum as well as hay (approx. 15 g daily)
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 ºC
- Humidity (%): 50±20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: 0.3 mL of 0.9% NaCl
Controls:
no
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 500 mg test substance in solution prepared with 0.3 mL 0.9% NaCl
Duration of treatment / exposure:
4 hours
Observation period:
The evaluations took place 30 - 60 minutes as well as 24, 48 and 72 hours after removing the patch.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: semi-occlusive bond

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removed carefully with lukewarm tap water
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
and scab formation
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
48 hours after removal of the patch, the animals had a very light, hardly perceptible erythema. The skin surface of the animals was beige discolored partial. 72 hours post application all animals were free from neurological irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The examination of skin irritation at the rabbit resulted in that the test substance is not related to the present investigation according to the classification criteria of the guideline 83/467/EWG and the hazardous material regulation labeling required.
Executive summary:

Rabbits were exposed dermally to the test substance for 4 hours under semi-occlusive conditions in accordance with OECD Guideline 404. The evaluations took place 30 - 60 minutes as well as 24, 48 and 72 hours after removing the patch. 48 hours after removal of the patch, the animals had a very light, hardly perceptible erythema. The skin surface of the animals was beige discolored partial. 72 hours post application all animals were free from neurological irritation.