Trilead bis(carbonate) dihydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

August-December 2003

Reliability:

1 (reliable without restriction)

Justification for data waiving:

other:

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

There was one deviation from the study protocol which was concerned with the relative humidity (section 6.2 Husbandry). On some days of the study the relative humidity was higher than 70%.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trilead dioxide phosphonate

EC Number:

235-252-2

EC Name:

Trilead dioxide phosphonate

Cas Number:

12141-20-7

Details on test material:

- Name of test material (as cited in study report): ALLSTAB LP 3139 dibasic lead phosphite
- Molecular formula (if other than submission substance): 2PBO x PbHPO3 x 0,5 H2O
- Physical state: fine white powder
- Analytical purity: 99.3%
- Composition of test material, percentage of components: 82.7% Pb; 0.2% water;
- Lot/batch No.: 210510067
- Expiration date of the lot/batch: >24 months after shipping
- Storage condition of test material: At room temperature. min. 24 months (after shipment), when stored in sealed containers at temperatures below 40 degrees centigrade.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann
- Weight at study initiation: 2.74, 2.75 and 3.26 kg.
- Housing: The rabbits were housed individually in a battery of cages with a cage size of 100 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet ad libitum
- Water (e.g. ad libitum): Tap water as used for human consumption was continuously available ad libitum.
- Acclimation period: The animals were acclimatised to laboratory conditions for more than 5 days. Animals have been housed at the testing facility for 20 days or several months.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees centigrade
- Humidity (%): 44-72%
- Air changes (per hr): 16 times/h and filtered adequately
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light with light on at 7:00 AM

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: The skin of the back of all animals was clipped 24 h before treatment and examined for potential lesions.

Vehicle:

unchanged (no vehicle)

Controls:

other: The test article was applied to the right side of the back and the untreated left side served as the control

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

Skin reactions were assessed 1, 24, 48 and 72 hours after the end of the exposure.

Number of animals:

Three animals

Details on study design:

TEST SITE
- Area of exposure: Right side of the back. The untreated left side served as a control.
- Type of wrap if used: The test article was applied to a gauze patch and then applied to the skin

Results and discussion

In vivo

Results

Irritation parameter:

other: Grading of skin reaction as stipulated by OECD 404

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hours afer the time of exposure

Score:

0

Max. score:

0

Reversibility:

other: not relevant

Irritant / corrosive response data:

Very slight signs of erythema were seen 1 hour after patch removal in all three animals. Thereafter, no signs of erythma or oedema were observed. The mean grades at 24, 48 and 72 hours after the end of exposure were "0" in each animal.

Other effects:

No toxic effects with respect to the general condition were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: OECD 404

Conclusions:

The test article was classified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure according to the criteria specified by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "ALLSTAB LP 3139 dibasic lead phosphite" is classified as "non-irritant".

Executive summary:

The potential toxicity of "ALLSTAB LP 3139 dibasic lead phosphite" was assessed in an acute dermal irritation/corrosion test on three albino rabbits. In each animal, 0.5 g of the solid test article was applied on the right side of the dorsal clipped region, the untreated left side served as the control. Exposure duration was 4 hours. Both sides were examined at 1, 24, 48 and 72 hours after the end of exposure. The following results were obtained: -There were no skin irritating findings with the exception of very slight erythema observed 1 hour after patch removal in all three animals. -No general toxic effects were seen. -The mean grades at 24, 48 and 72 hours after the end of exposure were "0" in each animal. The test Article was classified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure according to the criteria specified by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "ALLSTAB LP 3139 dibasic lead phosphite" is classified as "non-irritant".

These results can be assigned to lead titanium trioxide since a read across based on a grouping of substances (Pb substances) is applied.