Lead Carbonate Intermediate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

August-December 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Well-documented and corresponded to the requirements of the recommended Annex V test guidelines.

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

Test material form:

solid: particulate/powder

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 PbPO3 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; minimum 24 months (after shipment), when stored insealed containers at temperatures below 40 degrees.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- 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


IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

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.
- % coverage:
- Type of wrap if used: The test article was applied to a gauze patch and then applied to the skin.


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

very slight signs of erythema observed 1 hour after patch removal

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

very slight signs of erythema observed 1 hour after patch removal

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

very slight signs of erythema observed 1 hour after patch removal

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.

Any other information on results incl. tables

Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.

See IUCLID Section 13 for Analogue approach report.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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".