Registration Dossier
Registration Dossier
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EC number: 203-704-8 | CAS number: 109-78-4
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline: Appraisal of the safety of chemicals in food, drugs and cosmetics, FDA, Draize, 1959
- Deviations:
- not specified
- Principles of method if other than guideline:
- Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials". - GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-hydroxypropiononitrile
- EC Number:
- 203-704-8
- EC Name:
- 3-hydroxypropiononitrile
- Cas Number:
- 109-78-4
- Molecular formula:
- C3H5NO
- IUPAC Name:
- 3-hydroxypropanenitrile
- Details on test material:
- - Name of test material (as cited in study report): ethylencyanhydrin
- Substance type: aliphatic nitrile
- Physical state: clear, colourless liquid
- Analytical purity: as supplied by producer: purity in the test report not mentioned, but probably > 98,5%
- Impurities (identity and concentrations): no data available by the study report but according to the current product information sheet the
impurities are: glykol <1%, formic acid: max 0.06%, HCN: max 0.0010% , water: max 0.10%.
- Stability under test conditions: no data available by the study report
- Storage condition of test material: no data available by the study report
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data available
- Weight at study initiation: 2.5-2.6 kg
- Housing: individual housing
- Diet (e.g. ad libitum): standard diet
- Water: ad libitum
- Acclimation period: no data availible
- Air changes (per hr): no data availible
- Photoperiod (hrs dark / hrs light): 12 h light/12h dark
- Humidity: 45-55%
- Room temperature: 20 ±1°C
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): undiluted 2.5 ml Etylencyanhydrin - Duration of treatment / exposure:
- 72 h
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: no data availible
- Type of wrap if used: gummed bandage to wrap up the body of the test animal.
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage.
- Time after start of exposure: 72 hours
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: reevaluated according CLP-criteria.
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: reevaluation according CLP criteria
- Remarks:
- mean 24 + 72 h
Any other information on results incl. tables
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Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Mean erythema score (average value of the single scores (animals 1-6; erythema; 24h and 72h) was determined to 0.17. No formation of oedema could be observed for any of the test animals within 72hours. Therefore the Mean oedema score (average value of the singles scores (animals 1-6;oedema; 24h and 72h) was determined to 0. With the test result of a mean Draize score of max 0.17 out of 4 scores, the test substance ethylencyanhydrin has to be classified - according to GHS classification criteria - as non irritant for skin (hazard category: none).
- Executive summary:
The Mean erythema score (average value of the single scores (animals 1-6; erythema; 24h and 72h) was determined to 0.17. No formation of oedema could be observed for any of the test animals within 72 hours. Therefore the Mean oedema score (average value of the singles scores (animals 1-6;oedema; 24h and 72h) was determined to 0. With the test result of a mean Draize score of max 0.17 out of 4 scores, the test substance ethylencyanhydrin has to be classified - according to GHS classification criteria - as non irritant for skin (hazard category: none).
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