Registration Dossier
Registration Dossier
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EC number: 601-161-5 | CAS number: 112110-16-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyl 5-methylpyridine-2,3-dicarboxylate
- EC Number:
- 601-161-5
- Cas Number:
- 112110-16-4
- Molecular formula:
- C10 H11 N O4
- IUPAC Name:
- Dimethyl 5-methylpyridine-2,3-dicarboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Skippack Farms, Skippack, Pennsylvania
- Age at study initiation: 10-13 weeks of age
- Housing: individually, in stainless-steel cages with slatted floors over dry bedding
- Diet (e.g. ad libitum): PMI Certified Rabbit Diet (#5322), ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17- 23 °C
- Humidity (%): 50% ± 20%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: test substance was moistened with water
- Controls:
- other: each animal had a test- and a control site of application on opposite sides of the dorsal midline.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): 0,5 ml distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24 hours, 48 hours and 72 hours after removal of the test material
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: The test material was applied to 2 x 2 inch gauze patch and applied to one side of the animal
- Type of wrap if used: The gauze patches were held in place with a hypoallergenic adhesive tape and the trunk wrapped in an impervious wrap consisting of a sheet of plastic covered by filter cloth.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the esposure period, the test sites were wiped with gauze pads moistened with tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: The application sites were scored using the Draize scale for evaluating the skin irritation potential (Draize, H. J., Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Assoc. of Food and Drug Officials of the United States, 3rd Printing, 1975, page 48).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.7
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 28 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Primary Irritation Index = 0.18
Any other information on results incl. tables
Scoring System for Skin Irritation according to the Draize scheme:
Erythema and Eschar Formation
No erythema ............................................................................................................ 0
Very slight erythema (barely perceptible) ................................................................... 1
Well defined erythema .............................................................................................. 2
Moderate to severe erythema .................................................................................... 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ............... 4
Edema Formation
No Edema ...................................................................................................................................... 0
Very slight edema (barely perceptible) ............................................................................................. 1
Slight edema (edges of the area well defined by definite raising) ........................................................ 2
Moderate edema (area raised approximately 1 mm.) ........................................................................ 3
Severe edema (area raised more than 1 mm. and extending beyond the area of exposure) ................. 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, 2,3-Pyridinecarboxylic acid, 5-methyl-, dimethyl ester does not need to be classified for skin irritation according to Regulation (EC) No. 1272/2008 and according to Directive 67/548/EEC.
- Executive summary:
Six male albino rabbits (New Zealand White strain) were used for the study. The rabbits were dosed with 500 mg, of the test substance, as received. The test material was applied to a 2 x 2 inch gauze patch, moistened with 0.5 mL of distilled water and applied to the left side of the animal. The right side of the animal served as the untreated control receiving 0.5 mL of distilled water. The application sites were examined for skin irritation at the following intervals after removal of the test material: 1 hour, 24 hours, 48 hours and 72 hours. The application sites were scored using the Draize scale for the evaluation of skin irritation. A very slight (4/6) erythema was observed at the 1 hour observation period. By the 24 hour observation period, all signs of irritation had resolved in all 6 test animlas.
No signs of systemic toxicity or mortality were observed during the study period.
The Primary Irritation Index was 0.18.
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