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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August-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:
Appropriate in vivo study was already available. No need to perform in vitro study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to
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). At some days of the study the relative humidity was higher than 70%.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): LITHARGE lead oxide
- Physical state: fine, yellow powder
- Analytical purity: 99.8% lead (II) oxide
- Composition of test material, percentage of components: PbO: 99.8; metallic Pb: 0.01; Pb3O4:0.003; Cu: 0.001: Fe: 0.0008
- Lot/batch No.: 210213
- Expiration date of the lot/batch: May 2005
- Storage condition of test material: At room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 2.67, 2.84 and 3.86 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 (pelleted diet, batch no. K088) offered ad libitum.
- Water (e.g. ad libitum): Tap water as for human consumptiion was continuously available ad libitum via drinking nipples.
- Acclimation period: The animals were acclimatised to laboratory conditions for more than 5 days. Animals were housed at the testing facility for 20 days or several months


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees centigrade
- Humidity (%): The relative humidity was kept between 44 and 72%.
- Air changes (per hr): Air was changed 16 times per hour and filtered adequately.
- Photoperiod (hrs dark / hrs light):12 hours dark/12 hours 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 hours before treatment and examined for potential lesions. Only healthy animals showing no evidence of abnormalities were allocated to the test. The untreated left side of the back served as control.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after exposure
Number of animals:
three albino rabbits
Details on study design:
TEST SITE
- Area of exposure: Clipped skin on the right side of the back of rabbit
- % coverage:
- Type of wrap if used: Gauze patch


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


SCORING SYSTEM:

Results and discussion

In vivo

Results
Irritation parameter:
other: Grading of skin as stipulated by OECD 404
Basis:
mean
Time point:
other: 24, 48, and 72 hours after the end of the 4 hour exposure
Score:
0
Max. score:
0
Irritant / corrosive response data:
There were no skin irritating findings with the exception of very slight signs of erythema observed 1 hour after patch removal in all three animals.
The mean grades at 24, 48, and 72 hours after the end of exposure were "0" in each animal.
Other effects:
No general toxic effects were seen

Applicant's summary and conclusion

Interpretation of results:
other: Not classified under EU (CLP) criteria. However, a conclusion cannot be made on GHS criteria.
Conclusions:
The test substance was classsified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure accordingto the EEC Directive 2001/59/EEC of 6 August 2001 and Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test substance "LITHARGE lead oxide" is classified as "non-irritant."
Executive summary:

The potential toxicity of "LITHARGE lead oxide" was assessed in an acute dermal irritation/corrosion test on three albino rabbits. In each animal, 0.5 g of the solid test substance was applied on the right side of the dorsal clipped region, the untreated left side served as 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:

-No signs of erythema and oedema were observed

-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 classsified 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 EEC Directive 2001/59/EEC of 6 August 2001 and Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test substance "LITHARGE lead oxide" is classified as "non-irritant."