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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:
weight of evidence
Study period:
From March 7, 2006 to April 11, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

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:
liquid
Details on test material:
- Name of test material (as cited in study report): Oxidet L-75
- Physical state: clear, colourless, slightly viscous liquid with an amine like odor
- Water solubility: Easily soluble in cold water
- Isomers composition: Not applicable
- Lot/batch No.: PHA007.1165
- Storage condition of test material: at room temperature
- Purity: 30% solution in water
- Expiry date: June 2007
-Storage condition of test material: 20 ± 5 ºC and in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Granja Cunícola San Bernardo, S.L. (Tulebras, Navarra, Spain)
- Age at study initiation: 10-13 weeks old
- Weight at study initiation: 2.4-3.0 kg
- Housing: The animals were housed individually in stainless steel cages with a grille floor placed on racks.
- Diet (e.g. ad libitum): standard rabbit diet (SAFE 112C; Batches: 50602 and 51114), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25 ºC
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 hours of light nad 12 hours of darkness every 24 hours.


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24, 48, 72 hours, 7 days and 14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remains of the test item were removed with distilled water.
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.11
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.78
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
No data
Other effects:
A loss of 30 grams in body weight was recorded between the day of administration and the 24 hours following it in the first rabbit administered, as was a loss of 110 grams in body weight between 48 and 72 hours after the administration. A loss of 70 grams in body weight was recorded in another animal between 72 hours and 7 days after the administration, and a loss of 10 grams between the day of administration and the 24 hours afterwards in the case of the remaining animal. However, a posterior recovery of the weight was observed in all the animals.

The behaviour and physical state of the rabbits was normal throughout the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The means of the erythema and edema evaluation 24, 48 and 72 hours after removing the patch in the animals after a 4-hour exposure to the test item, were 2.11 (erythema) and 0.78 (edema). Only one animal showed a mean score (24-72 h) greater than 2.3. Based on the CLP classification criteria, the test material should not be classified for skin irritation. Based on the DSD classification criteria, the test material should be classified as skin irritant, R38.
Executive summary:

The degree of primary dermal irritation caused by the test item was determined after application to the shaven skin of 3 rabbits. The study was carried out according to OECD guideline 404 and EU method B.4. Initially one animal was used, and 3 semiocclusive patches were applied sequentially during 3 minutes, 1 and 4 hours, respectively. A confirmation assay was then sequentially performed, applying a patch with the test item during 4 hours in another two animals. The means of the erythema and edema evaluations at 24, 48 and 72 hours after removing the patch in the animals after a 4 -hour exposure to the test item were 2.11 (erythema) and 0.78 (edema).