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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:
7 March 1989 - 10 March 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Read across to a similar substance. Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Justification for type of information:
See read-across justification in Section 13.
Cross-reference
Reason / purpose:
other: Target substance
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read across material
Justification for type of information:
See read-across justification in Section 13.
Reason / purpose:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects seen
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Description: White powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Accredited breeders; not otherwise specified.
- Age at study initiation: 12 – 20 weeks
- Weight at study initiation: 2.0 – 3.5 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum (Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK or suitable alternative)
- Water (e.g. ad libitum): ad libitum tap water from automatic mains.
The diet and water are routinely analyses and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: Minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 – 21 °C
- Humidity (%): 40 – 75 %
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of test material moistened with 0.5 mL of distilled water and applied to 1 intact site of each rabbit.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
PROCEDURE
Method of Application: Test material introduced under gauze patch (2.5 x 2.5 cm) and secured on shorn skin by a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent interference the trunk of each animal wrapped in elasticated corset (TUBIGRIP) for duration of exposure period.
Exposure Period: 4 hours after which dressings removed and application sites decontaminated by cotton wool soaked with water or suitable solvent.

OBSERVATIONS
Skin Evaluation: Scored according to the method of Draize (1959)
Intervals: One hour after removal of patches and approximately 24, 48 and 72 hours later. If no adverse skin reactions at 72 hours, the study is complete. If irritation is persistent, additional observations will be made on days 7 and 14 as necessary to assess reversibility or irreversibility of effects observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Irritant / corrosive response data:
Corrosive effects noted in 0 animals, test material therefore classified as non-corrosive

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Non-irritant
Executive summary:

The test material was determined to be non-irritating and non-corrosive according to Draize. The study assessed the irritancy potential of a test material following a single, 4-hour, semi-occluded application to intact rabbit skin. (OECD Guidelines for Testing of Chemicals 1981, No. 404 "Acute Dermal Irritation/Corrosion" and Annex V Method B4 of EEC Commission Directive 84/449/EEC).