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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:
1985-07-29 to1985-08-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
control test was not performed
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-57-2
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-254
- Purity of test substance: responsibility of the Sponsor
- Stability under test conditions: no apparent changes in the physical state during administration
- pH=8.82

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Age at study initiation: adult
- Weight at study initiation: 2.123 - 2.294 kg
- Housing: individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): fresh tap water, fit for human consumption, ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/site, 4 sites per animal (2 abraded, 2 intact sites)


Duration of treatment / exposure:
24h
Observation period:
at 24 and 72h after application of the substance
Number of animals:
6 (3M and 3F)
Details on study design:
TEST SITE
- Area of exposure: 4 sites on the trunk of the animal ( clipped free of fur)
- Type of wrap if used: the trunk of the animal was wrapped with a rubber dam and an Ace bandage to retard evaporation.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): "substance is removed in a suitable manner"
- Time after start of exposure: 24h


SCORING SYSTEM:observation
Draize Evaluation of Dermal Irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72h exposure
Score:
0.2
Remarks on result:
other: slight dermal irritation
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 24h
Score:
0
Max. score:
4
Remarks on result:
other: intact sites
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 24h
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 72h after application
Remarks on result:
other: abraded sites. 4/12 sites= 0; 7/12 sites= 1; 1/12 sites= 2
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: 24h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 72h after application
Remarks on result:
other: intact sites: 12/12 sites= 0; abraded sites: 10/12 sites= 0; 2/12 sites= 1
Irritant / corrosive response data:
All scores returned to normal at the 72 hour observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
The test substance was considered to cause slight dermal irritation (PDII=0.2 at the 24 and 72h exposure according to Draize scoring system).
All scores returned to normal at the 72 hour observation. As no mean values of > or = 2.3 and < or = 4.0 for erythema or oedema are observed in at least 2 or 3 tested animals from gradings at 24h and 72 h after patch removal and as effects returned to normal after 72 hours, the substance should not be classified as irritant according to the criteria laid down in the CLP Regulation (EC) 1272/2008.