Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

EC Number:

913-404-5

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

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