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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:
2008-06-03 to 2008-06-16
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): LCE08086
- Substance type: Lipoamino acid
- Physical state: liquid
- Analytical purity: 31% dry extract
- Purity test date: 2008/03/28
- Lot/batch No.: 0807000020
- re-test date of the lot/batch: 2011/03/10
- 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 de Gérome (Quartier Labaste –F40260 Linxe)
- Age at study initiation: 11 to 12 weeks old.
- Weight: During the test, the animals weighed between 2.43 kg and 2.86 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 39% and 52%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
- Diet (e.g. ad libitum): freely (foodstuff (SDS –C15))
- Water (e.g. ad libitum): freely (tap-water from public distribution system)
- Acclimation period: minimal 5-day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
the test item was
applied, as supplied, at a dose of 0.5 mL
Duration of treatment / exposure:
the test item was applied during 4 hours
Observation period:
1 hour and then 24, 48 and 72 hours after removal of the patch
Number of animals:
Three male
Details on study design:
The TI was exposed on an area of skin about 6 cm2.
The patch was secured in position with a strip of surgical adhesive tape. After the removal of the patch, the treated area was rinsed with distilled water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h-48h-72h
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: mean score
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h-48h-72h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: mean score
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h-48h-72h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: mean score
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h-48h-72h
Score:
ca. 0
Reversibility:
other: not applicable
Remarks on result:
other: mean score
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h-48h-72h
Score:
ca. 1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: mean score
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24h-48h-72h
Score:
ca. 0
Reversibility:
other: not applicable
Remarks on result:
other: mean score
Irritant / corrosive response data:
A well defined erythema associated with a very slight oedema was noted on the treated area, at the
reading time one hour. The oedematous reactions were totally reversible between D1 and D2, and the
erythematous reactions were totally reversible between D2 and D6.
On the cutaneous structure, a slight dryness was noted on the treated area, from D3 in two animals.
The skin recovered a normal aspect between D6 and D7.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item
LCE08086, according to the scales of interpretation retained:
- is slightly irritant to skin (PSi = 0.8) according to the classification established in the Journal
Officiel de la République Française dated February 21st, 1982,
- and, must not 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 phrases are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be
classified in category 2 “irritant”. No signal word and hazard statement are required.
Executive summary:

The test item LCE08086 was applied, as supplied, at the dose of 0.5 mL, 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. A well defined erythema associated with a very slight oedema was noted on the treated area, at the reading time one hour. The oedematous reactions were totally reversible between D1 and D2, and the erythematous reactions were totally reversible between D2 and D6. On the cutaneous structure, a slight dryness was noted on the treated area, from D3 in two animals. The skin recovered a normal aspect between D6 and D7. The results obtained, in these experimental conditions, enable to conclude that the test item LCE08086 must not 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 phrases are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 “irritant”. No signal word and hazard statement are required.