Registration Dossier
Registration Dossier
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EC number: 921-820-3 | CAS number: -
Skin irritation / corrosion
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: This study was conduced following an accepted OECD guideline and in compliance with the Good Laboratory Practice.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- COS 98091
- IUPAC Name:
- COS 98091
- Details on test material:
- Appearence: white powder
Code in the laboratory: 98-4493
Storage: at ambiant temperature and out of the light in a roomespecially fitted out to that effect
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: new zealand albino rabbits
Origin: JEGARD Supplier (22120 Yffiniac, France)
Weight: superior to 1.8 kg the day before application of the substance
Number and sex: 3 males
Identification: each animal was identified by auricular ring and the corresponding number was written on a label put on its cage
Housing: animals were individually housed, in stainless steel cages
Air conditionned temperature: 20 +/- 3°C
Controlled relative humidity: 50 +/- 20 %
Artificial lighting: 12/12
Feeding: the complete diet was supplied under pelleted from ERGILAP Anco delivered by COFNA (37018 Tours , France)
Drinking: tap water distributed in polypropylene feeding-bottles with stainless steel teat.
Preparation of the animals and selection
Approximately 24 hours before application of the substance, fur was removed by close-clipping the dorsal area of the trunk of the animals.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- substance impregnated with distilled water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
The substance was impregnated with distilled water - Duration of treatment / exposure:
- The rabbits kept the semioclusive patch for 4 hours.
- Observation period:
- Animals were examined for signs of erythema and oedema and the responses scored at 1 hour, and then at 24, 48, 72 hours after the patch removal.
- Number of animals:
- Three animals.
- Details on study design:
- A dose of 0.5 g of test substance was applied to a square of gauze patch of 2.5*2.5 cm (6 cm²) put on a Micropore tape of 5*5 cm (25 cm²).
The semi-occlusive dressing was applied to the clipped skin and held in place with an extensible bandage which surrounded the trunk of the animal and was fixed with Micropore.
the rabbits were put back into their cages for 4 hours and then the patch was removed. Residual test substance was removed using an absorbent paper moistered with distilled water or an appropriate solvent.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 48
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 48
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 48
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 48
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 48
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 72
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 72
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 72
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 72
- Score:
- ca. 0
- Irritant / corrosive response data:
- nothing to report
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Taking into account the criteria defined by the EEC 67/548 directive and its successive amendements,
COS 98091 (Montanov L) was not classified among the substances irritant to skin. - Executive summary:
The aim of the test was to assess qualitively and quantitatively the irritant or corrosive effect and the rate of onset after single application to skin, of the substance COS 98091 (Montanov L), in the rabbit.
The test substance was applied in a single dose (0.5 g) , under semi-occlusive patch, at 3 animals, one untreated skin area serving as control.
The degree of irritation was read and scored at specified intervals.
The duration of the test was suffcicient to evaluate fully the reversibility of the effects observed.
The albino rabbit is the mammalian species commonly used and recommended by the official authorities for the assessment of the cutaneous tolerance of chemical substances by this kind of method.
This test enabled to classify the test sunstance in one of the categories defined in the order of april 20, 1994 taken enforcement from the basic Directive 67/548/EEC and its successive amendements.
the methodology followed the OECD guideline n°404 of July 17, 1992, concerning the tests of chemical products, which defines dermal irritation as the production of reversible inflammatory changes in the skin, and the dermal corrosion as the production of irreversible tissue damage after application of the test substance.
Animals were examined for signs of erythema and oedema and the responses scored at 1 hour, and then at 24, 48, 72 hours after the patch removal.
For the clinical observations, there was nothing to report.
Taking into account the criteria defined by the EEC 67/548 directive and its successive amendements, COS 98091 (Montanov L) was not classified among the substances irritant to skin.
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