Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From May 31 to June 03, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
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: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: between 2190 to 2310 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: A gauze patch (approx. 12-16 cm2) bearing 0.5 g of test substance


Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze patch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 071/M, 197/M, 187/M
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal: 071/M, 197/M, 187/M
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: No deremal effects observed

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation
Conclusions:
Not irritating.
Executive summary:

Method:

The Skin irritation was determined in an irritation test on rabbits according to the OECD Guideline 404 and the EU Method B.4.

Result:

Not irritating