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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2007-07-31 to 2007-08-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read across from a member of the category

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): LCE07050
- Physical state: solid , powder
- Analytical purity: 100%
- Composition of test material, percentage of components: 67762-27-0, 54549-27-8, 27836-65-3
- Lot/batch No.: T70615
- Expiration date of the lot/batch: 07 February 2009 (re-test)
- Storage condition of test material: at the room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Test animals:
Three male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste –
F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the
animals weighed between 2.22 kg and 2.63 kg.

Housing:
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19°C and 23°C
- relative humidity : between 47% and 65%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the test item.
Number of animals:
3 animals

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item LCE07050 according to the scales of interpretation dont' need to be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
Executive summary:

The test item LCE07050 was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing

during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established

from the O.E.C.D. guideline n° 404 dated April 24th, 2002 and the test method B.4 of the directive n°

2004/73/EC.

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24,

48 and 72 hours).

The results obtained, under these experimental conditions, enable to conclude that the test item

LCE07050 need not to be classified, according to the criteria for classification, packaging and

labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548,

2001/59 and 99/45. No symbol and risk phrase are required.