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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:
2008-05-13 to 2008-05-23
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:
not specified
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): LCA08002
- Substance type: Lipoamino acid
- Physical state: solid powder
- Analytical purity: 100%
- Lot/batch No.: 1549JG
- Expiration date of the lot/batch: 2009-04-10
- 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: 12 to 13 weeks old
- Weight at study initiation: 2.72 kg to 3.12 kg
- Housing: Individual box
- Diet (e.g. ad libitum): SDS-C15 supplied freely
- Water (e.g. ad libitum): tap-water from public distribution system-supplied freely
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 22°C
- Humidity (%): 34% to 54%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12h hours daily

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5g pure
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 75 hours
Number of animals:
3
Details on study design:
Approximately 24 hours before the test, the rabbits backs and flanks were shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm2.
As no tissue destruction was notedafter a treatment during 3 minutes and 1 hour, the test item was applied, as supplied, at a dose of 0.5g, on an undamaged skin area of one flank of each animal, during 4 hours. 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.
On the opposite flank an untreated area was served as the control.
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the dirst treated animal, two additional animals were treated during 4 hours.
The skin reaction were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
This examination consists in assessing the irritation reactions in the treated zone, compared to a control area.
If no reaction is observed 72 hours after the treatment, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D14 in order to determine the reversibility character of the lesions observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
no data
Remarks:
not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
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: other: the Journal Officiel de la République Française dated February 21st, 198
Conclusions:
The results obtanied, under these experimental conditions, enable to conclude that the test item LCA08002, according to the scales of interpretation retained :
- Is non irritant to skin (PS1=0) 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 Globaly 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 LCA08002 was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of the three rabbits. The experimental protocol was established from the OECD 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 obtanied, in these experimental conditions, enable to conclude that the test item LCA08002, 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 Globaly 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.