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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:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: ≥ 92%- pH: ≥ 1 - ≤ 5 (aqueous preparation)
Specific details on test material used for the study:
- Name of the test material: JODOSEPT L- Description: brown liquid- Batch no.: ZK 1055/175-2- Storage: at room temperature away from direct sunlight

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS - Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne - Age at study initiation: 15 weeks - Weight at study initiation: male 2771 g, females 2858 and 2671 g - Housing: individually in stainless steel cages with an automatic cleaning system with feed hoppers, drinking water bowls, with haysticks and wood for gnawing - Diet: pelleted standard Kliba 3410 rabbit maintenance diet (Provimi Kliba AG, 4303 Kaiseraugst, Switzerland), ad libitum - Water: community tap water from Itingen, ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20 ± 3 - Humidity (%): 40 - 70 - Air changes (per hr): 10 - 15 - Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE - Area of exposure: 6 cm2 dorsal skin- Type of wrap if used: 2.5 cm x 2.5 cm patch of surgical gauze covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. REMOVAL OF TEST SUBSTANCE - Washing: after the dressing was removed the skin was washed with lukewarm tap water - Time after start of exposure: 4 hoursOBSERVATION TIME POINTS1, 24, 48 and 72 hours after removal of the dressing, gauze patch and test article.SCORING SYSTEM: - Method of calculation: a numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992OBSERVATIONS- Viability/mortality: daily- Clinical signs: daily during the observation period- Body weights: At start of acclimatization, on the first day of application and at termination of observation.- Pathology: No necropsy was performed.

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
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred . The body weight of all rabbits were considered to be within the normal range of variability. Brown staining by the test article of the treated skin was observed .

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met