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Registration Dossier
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EC number: 309-913-1 | CAS number: 101357-16-8
Endpoint summary
Administrative data
Description of key information
Skin irritation:
Key study: Equivalent to OECD 404. No GLP study.
Based on the available results, the test substance is not classified as skin irritating.
Eye irritation:
Key study: Equivalent to OECD 405. No GLP study.
Based on the available results, the test substance is not classified as eye irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to OECD 404. No GLP study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no data recorded on body weights, the exposure period was 24 hours instead of 4 h, the applied amount of the test substance was lower than that recommended in the guidelines)
- Principles of method if other than guideline:
- Modification of the method described by Draize (1944).
- GLP compliance:
- no
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approx. 3 kg
- Housing: Individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A solution of 0.4 g/ml of the test substance in distilled water was prepared. 0.5 ml of this solution were applied to the animals. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: sterile gauze and wax paper.
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beefy redness) to eschar formation 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the available results, the test substance is not classified as skin irritating.
- Executive summary:
The test item was applied only once to the shaved skin of three animals. The exposure lasted 24 hours. Observations of the treated skin were performed at 24, 48 and 72 hours after the end of the exposure. Based on the available results, the test substance is not classified as skin irritating.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
See 'Justification for data waiving'
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to OECD 405. No GLP study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no data recorded on body weights)
- GLP compliance:
- no
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approx. 3 kg
- Housing: Individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week - Vehicle:
- other: ethyl alcohol (10%)
- Controls:
- other: the vehicle was applied to the control eyes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A solution of 0.4 g/ml of the test substance in ethyl alcohol (10%) was prepared. 0.1 ml of this solution were applied to the animals´treated eyes (equivalent to 40 mg of the test substance). - Observation period (in vivo):
- 1, 24, 48 hours, 5 and 7 days
- Number of animals or in vitro replicates:
- Three animals
- Details on study design:
- SCORING SYSTEM:
Cornea
Opacity:
No ulceration or opacity 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, iris reactive to light (a sluggish reaction is considered to be an effect) 1
Hemorrhage, gross destruction, or no reaction to light 2
Conjunctivae
Redness:
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis
Normal 0
Some swelling above normal 1
Obvious swelling, with partial eversion of lids 2
Swelling, with lids about half closed 3
Swelling, with lids more than half closed 4 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Instead 72h the 5d reading was done.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Instead 72h the 5d reading was done.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Instead 72h the 5d reading was done.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the available results, the test substance is not classified as eye irritating.
- Executive summary:
The test item was applied to one eye of each of the three animals. Observations of the treated eyes were performed at 1, 24, 48 hours, 5 and 7 days after the start of the exposure. Based on the available results, the test substance is not classified as eye irritating.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
See: 'Justification for data waiving'
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Key study: Equivalent to OECD 404. No GLP study.
Based on the available results, the test substance is not classified as skin irritating.
Eye irritation:
Key study: Equivalent to OECD 405. No GLP study.
Based on the available results, the test substance is not classified as eye irritating.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available. Klimisch 2. Equivalent to OECD 404. No GLP study.
Justification for selection of eye irritation endpoint:
Only one study available. Klimisch 2. Equivalent to OECD 405. No GLP study.
Justification for classification or non-classification
Based on the available data, the substance is not classified for irritation/corrosion.
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