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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: GLP study, OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2001-18-04

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Container : plastic tube (n=2)
• Form : thick liquid
• Quantity : 118.80g (Container + Content)
• Colour : yellow - brown
• Batch : 4359 MP
• Storage: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
3 male albinos rabbits, numerated A3993, A3994 and A3995 of new-Zealand strain, originating from
the Elevage de Gérome (Quartier Labaste – 40260 Linxe) were kept during a 7 -day acclimatisation
period. During the test, the animals weighted between 2.13kg and 2.31kg.
The animals were kept in individual boxes installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19 °C and 23 °C
- relative humidity : between 51% and 68%

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
up to 3 days
Number of animals:
3
Details on study design:
The test product was applied, as supplied, at a dose of 0.5mL, on an undamaged skin area of the right
flank of each animal.
On the left flank was applied, in the same experimental conditions, a dose of 0.5mL of distilled water
on an undamaged skin area.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
The results obtained, in these experimental conditions, enabled to conclude that the test product
LCA01006, according to the scales of interpretation retained :
- is non irritant to skin (PSi =0) according to the classification established in the Journal Officiel de
la République Française dated February 21st, 1982,
- and, must not be classified “R35 : causes severe burns”, “R34 : causes burns” or “R38 :
irritant to skin”, according to the criteria for classification, packaging and labelling of dangerous
substances in compliance with the E.E.C. Directives 67/548 and 93/21.
Executive summary:

The product LCA01006 was applied, as supplied, at the dose of 0.5mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits, according to an experimental protocol established from the O.E.C.D. guideline (n° 404 dated July.17th,1992) and the method B.4 of the directive 92/69/E.E.C. dated December 29th,1992.

No cutaneous reactions (erythema and oedema) were observed in any animal whatever the examination time.

The results obtained, in these experimental conditions, enabled to conclude that the test product LCA01006, according to the scales of interpretation retained : - is non irritant to skin (PSi = 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 in compliance with the E.E.C. Directives 67/548 and 93/21.