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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reference
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

No erythema and no edema was observed. Score = 0 at any time point

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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

The test substance is not irritating to the eyes

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.

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.