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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
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 data waiving:
other:

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). On some days of the study the relative humidity was higher than 70%.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PEBETAL dibasic lead phthalate
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: fine, white powder
- Analytical purity: 74.15% Pb= 97.6% Pebetal
- Impurities (identity and concentrations):
- Composition of test material, percentage of components: ash: 79.3%; water: 0.2%
- Isomers composition:
- Purity test date:
- Lot/batch No.: D1/4296
- Expiration date of the lot/batch: July 31, 2004
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: At room temperature; Shelf life; at least one year after dispatch
- Other:

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: 2.97, 3.09, 3.26 kg
- Housing: The rabbits have been housed individually in a battery of cages with a cage size 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 consumption was continuously available ad libitum via drinking nipples.
- Acclimation period: The animals were acclimatised to the laboratory for more than 5 days. Animals were housed at the testing facility for 20 days or several months.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- degrees centigrade
- Humidity (%): 44-72%
- Air changes (per hr): Air was changed about 16 times per hour 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:
other: The skin of the back of all animals was clipped 24 hours before treatment and examined for potential lesions.
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left side of the back served as control.
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, and 72 hours after the exposure period.
Number of animals:
Three male rabbits
Details on study design:
TEST SITE
- Area of exposure: The right side of the back of the rabbit.
- % coverage:
- Type of wrap if used: The test article was applied to a gauze patch and then applied to the skin. To ensure good contact with the skin, 2-3 drops of peanut oil were used. The closed patch exposure was effected by means of a semi-occlusive bandage using Ypsiplast , nonirritating tape Elastoplast and Stulpa, which enveloped the whole of the animal's trunk.


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 Reaction as stipulated by OECD 404
Basis:
mean
Time point:
other: 24, 48 and 72 hours after the 4 hour exposure
Score:
0
Max. score:
0
Irritant / corrosive response data:
No signs of erythema 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 EEDC 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 is classified as "non-irritant".
Executive summary:

The potential toxicity of "PEBETAL dibasic lead phthalate" 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 ledt 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 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 (GefDtoffV) of 15 November 1999 (BGB1.I, p.2233). When applied to the skin, the test article "PEBETAL dibasic lead phthalate" may therefore be classified as "non-irritant".