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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:
other: Study carried out according to OECD guideline 404 well documented and scientifically acceptable
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were male rabbits, new zealand white. They weighed between 3 and 4 kg and were kept in separate cages at a temperature between 19 and 25oC and a relative humidity between 40 and 60%. The day/night rhytm was 12/12 hours. The animals were fed with a standard diet and were allowed to drink tap water ad libitum.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Two patches were shaved, one served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg


Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
The study was carried out according to guideline 404. The skin of three male white rabbits was exposed to 500 mg Bayferrox VP AC 5122. This was applied semi-occlusive to a patch of shaved skin. A second patch of shaved skin was used as a control. Exposure was for 4 hours and after exposure the skin was rinsed with water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: each animal was evaluated individually
Time point:
other: 1, 24, ,48, 72 and 168 hrs
Score:
0
Max. score:
0
Remarks on result:
other: No efects found at at any time point for any animal
Irritation parameter:
edema score
Basis:
other: each animal was evaluated individually
Time point:
other: 1, 24, 48, 72 and 168 hrs
Score:
0
Max. score:
0
Remarks on result:
other: No edema was observed on any animal at any point in time
Other effects:
not observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Bayferrox VP AC 5122 M-Investigation of its primary irritation/corrosion on the rabbit skin. The test material is not irritating.
Executive summary:

In a primary dermal irritation study 3 New Zealand white rabbits were dermally exposed to 500 mg of Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%) in water for 4 hours. Animals then were observed for 7 days. The study was performed according to the OECD Guidelines 404 for acute dermal irritation/corrosion. Bayferrox VP AC 5122 M (Fe2O3 83.5 %, FeO 12%, Co 4.5%) did not cause dermal irritation.