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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:
13 November 1996 to 30 April, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Method B4, Commission Directive 92/69/EEC
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Les Dombes, France
- Age at study initiation:approximately 19 weeks old
- Weight at study initiation: 3 kg
- Housing:singly, wire mesh bottom stainless steel cages
- Diet (e.g. ad libitum): ad libitem
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20+-2C
- Humidity (%):45-75%
- Air changes (per hr):10-12
- Photoperiod (hrs dark / hrs light):12/24 hr

IN-LIFE DATES: From: November 13 To: November 19th, 1996

Test system

Type of coverage:
semiocclusive
Vehicle:
other: The substance was moistened with water and applied to the animal.
Controls:
other: contralateral zone of same animal
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
1 hr, 24hr, 48hr and 72hr after dressing removed
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 14 cm3
- % coverage:
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):none
- Time after start of exposure: none

SCORING SYSTEM: erythema and edema: non-irritating if score is < 2 using mean score at 24+48+72 in at least 2 out 3 animal. If >= 2 then assigned R 36- irritating to skin classification.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
1
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
There was no sign of dermal effects.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was classified as non irritating to the skin.