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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Centre International de Toxicologie, France

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6 DCPTFMA
- Physical state: solid
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle, 80160 Prouzel, France
- Weight at study initiation: mean: 2.5 ± 0.1 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance in its original form was applied. Pre-moistened with 0.5 ml of water for injections.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 15 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: hydrophilic gauze patch (Semes France, 54183 Heillecourt, France)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with a gauze patch saturated with water for injections
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.9
Max. score:
4
Reversibility:
fully reversible within: 14 days, one animal showed on d14 still dryness of the skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72
Score:
2
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritant / corrosive response data:
Moderate cutaneous reactions were observed for up to 72 hours after removal of the dressing.
They consisted of erythema (Scores of 1 to 2 in 3 animals) and oedema (score of 2 in 3 animals).
The mean score over 24, 48 and 72 hours for individual animals was 1.7, 2.0 and 2.0 for erythema and 2.0. 2.0 and 2.0 for oedema.
Between days 5 and 15 a dryness of the skin was observed at the treatment site. No ulceration or necrosis was noted.
Other effects:
No other effects were observed.

Any other information on results incl. tables

Exposure period: 4h
Readings Animal No. Erythema Edema Additional findings
24 h 1 2 2  
2 2 2  
3 2 2  
48 h 1 2 2  
2 2 2  
3 2 2  
72 h 1 1 2  
2 2 2  
3 2 2  
5 d 1 1 0 S
2 2 0 S
3 2 0 S
7 d 1 0 0 S
2 2 0 S
3 1 0 S
9 d 1 0 0 S
2 1 0 S
3 0 0 S
14 d  1 - -  
2 0 0  
3 0 0 S
mean 24 - 72 h 1 1.7 2  
2 2 2  
3 2 2  
       
mean 24 - 72 h mean 1.9 2.0

S: dryness of the skin

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS