Tin zinc oxide (SnZnO3)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 March 1989 - 10 March 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read across to a similar substance. Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Justification for type of information:

See read-across justification in Section 13.

Cross-reference

Reason / purpose for cross-reference:

other: Target substance

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted on read across material

Justification for type of information:

See read-across justification in Section 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects seen

Irritation parameter:

edema score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Description: White powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited breeders; not otherwise specified.
- Age at study initiation: 12 – 20 weeks
- Weight at study initiation: 2.0 – 3.5 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum (Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK or suitable alternative)
- Water (e.g. ad libitum): ad libitum tap water from automatic mains.
The diet and water are routinely analyses and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: Minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 – 21 °C
- Humidity (%): 40 – 75 %
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g of test material moistened with 0.5 mL of distilled water and applied to 1 intact site of each rabbit.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

PROCEDURE
Method of Application: Test material introduced under gauze patch (2.5 x 2.5 cm) and secured on shorn skin by a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent interference the trunk of each animal wrapped in elasticated corset (TUBIGRIP) for duration of exposure period.
Exposure Period: 4 hours after which dressings removed and application sites decontaminated by cotton wool soaked with water or suitable solvent.

OBSERVATIONS
Skin Evaluation: Scored according to the method of Draize (1959)
Intervals: One hour after removal of patches and approximately 24, 48 and 72 hours later. If no adverse skin reactions at 72 hours, the study is complete. If irritation is persistent, additional observations will be made on days 7 and 14 as necessary to assess reversibility or irreversibility of effects observed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects seen

Irritant / corrosive response data:

Corrosive effects noted in 0 animals, test material therefore classified as non-corrosive

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Non-irritant

Executive summary:

The test material was determined to be non-irritating and non-corrosive according to Draize. The study assessed the irritancy potential of a test material following a single, 4-hour, semi-occluded application to intact rabbit skin. (OECD Guidelines for Testing of Chemicals 1981, No. 404 "Acute Dermal Irritation/Corrosion" and Annex V Method B4 of EEC Commission Directive 84/449/EEC).