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Registration Dossier
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EC number: 255-460-7 | CAS number: 41611-76-1
Endpoint summary
Administrative data
Description of key information
A valid skin irritation/corrosion and eye irritation study are available:
Skin irritation/corrosion - OECD 404, K, Rel.2 - not irritating
Eye irritation - OECD 405, K, Rel.2 - not 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:
- guideline study without detailed documentation
- Remarks:
- Study performed according to the OECD TG 404
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- 500 µl of the test substance formulated in glycerin were placed on a plaster and applied on the skin of 3 rabbits. After 4 hours the plaster was removed and the exposed skin area was cleaned with water.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with an electrical hair clipper
- Vehicle:
- other: glycerin
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 animals
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Executive summary:
500 µl of the test substance formulated in glycerin were placed on a plaster and applied on the skin of 3 rabbits. After 4 hours the plaster was removed and the exposed skin area was cleaned with water.
No erythema and no edema was observed. Score = 0 at any time point. Macrolex Blau CA 51056 is not irritating to the skin (exposure time = 4 hours).
Reference
No erythema and no edema was observed. Score = 0 at any time point
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:
- guideline study
- Remarks:
- Study performed in compliance with OECD TG 405
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- 100 µl (ca. 40 mg) test substance was applied into the conjuctival sac of 3 rabbits. The treated eye was washed after 24 hours with physiological saline. Eyes were examinated after application of test substance for 7 days
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- A slight reddening of the cornea was visible 1 hour after application of the test substance, possibly caused by mechanical irritation of the test item
- Interpretation of results:
- GHS criteria not met
- Executive summary:
100 µl (ca. 40 mg) Macrolex Blau CA 51056 = CAS 41611-76-1 was applied into the conjuctival sac of 3 rabbits. The treated eye was washed after 24 hours with physiological saline. Eyes were examinated after application of the test substance for 7 days. Cornea, iris, conjunctiva (erythema and chemosis) were scored according to Draize at 24, 48 and 72 hours. Mean values (24, 48 and 72 h) for cornea score = 0, iris score = 0, conjuctivae score = 0 and chemosis score = 0. The test substance is not irritating.
Reference
The test substance is not irritating to the eyes
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
500 µl of the test substance formulated in glycerin were placed on a plaster and applied on the skin of 3 rabbits. After 4 hours the plaster was removed and the exposed skin area was cleaned with water. Erythema/scab building and edema were scored according to Draize at 24, 48 and 72 hours. No erythema and no edema was observed. Score = 0 at any time point. Macrolex Blau CA 51056 is not irritating to the skin (exposure time = 4 hours).
Eye Irritation
100 µl (ca. 40 mg) Macrolex Blau CA 51056 = CAS 41611-76-1 was applied into the conjuctival sac of 3 rabbits. The treated eye was washed after 24 hours with physiological saline. Eyes were examinated after application of the test substance for 7 days. Cornea, iris, conjunctiva (erythema and chemosis) were scored according to Draize at 24, 48 and 72 hours. Mean values (24, 48 and 72 h) for cornea score = 0, iris score = 0, conjuctivae score = 0 and chemosis score = 0. The test substance is not irritating.
Justification for selection of skin irritation / corrosion endpoint:
key study used
Justification for selection of eye irritation endpoint:
key study used
Justification for classification or non-classification
Due to the results of the skin irritation/corrosion and eye irration study a classifiation is not justified in accordance with CLP Regulation No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
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