Lead dioxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

September-December 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well-documented and corresponded to the requirements of the recommended Annex V Test Guidelines.

Justification for type of information:

Read-across from supporting substance (structural analogue or surrogate), same metal ion than the substance of interest

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Lead monoxide

EC Number:

215-267-0

EC Name:

Lead monoxide

Cas Number:

1317-36-8

Molecular formula:

OPb

IUPAC Name:

Plumbanone

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated left eye served as the control

Amount / concentration applied:

Amount applied: 0.1g

Duration of treatment / exposure:

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

Three male rabbits used in the test were acclimatised to laboratory conditions for 27 days or several months. Twenty four hours before treatment, the eyes of all animals were examined for potential ocular lesions. Since the animals did not show ocular abnormalities, they were allocated to the test.The solid article was used as supplied by the Sponsor. One of the animals (rabbit no.1) was treated in advance in order to assess ocular reactions to the test article. The animal was treated with 0.1g of the solid test article, which was introduced into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about 1 second in order to limit loss of the test article. The untreated left eye served as the control. Since there was no remarkable response to the instillation of the test article within a few days, the further two animals were treated subsequently in the same manner.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days after instillation

Irritant / corrosive response data:

Slight redness (grade 1) of the conjunctiva occurred in animal no.1 at 1 h after instillation and disappeared subsequently. No ocular findings were seen between 24 h after instillation and the end of observation 72 h after instillation. The mean grades of erythema at 24, 48 and 72 h after instillation were "0" in all animals.

Other effects:

No general toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: OECD 405

Conclusions:

When administered to the eye, the test article is classified as "non-irritant."

Executive summary:

The purpose of this study was to assess irritant and/or corrosive effects of LITHARGE lead oxide on eyes and associated mucous membranes following ocular administration to rabbits. Information derived from this test serves to indicate the existence of possible hazards likely to arise from exposure of the eye to the test article.

The potential toxicity of LITHARGE lead oxide was assessed in an acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1g of the test article was introduced into the conjunctival sac of the right eye, the untreated left eye served as control. Both eyes were examined at 1, 24, 48 and 72 hours post applicationem. The following results were obtained:

Between 24 and 72 hours after instillation no ocular findings were seen. The only finding was slight redness of the conjunctivae in one animal 1 h after instillation.

No general toxic effects were observed.

The mean grades of ocular reactions 24, 48 and 72 hours after instillation were "0" in each animal.

The test article was classsified according to the EEC directive 2001/59/ECC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When administered to the eye, the test article LITHARGE lead oxide may therefore be classified as "non-irritant."