Registration Dossier

Administrative data

Description of key information

A valid skin irritation/corrosion and eye irritation study are available

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:
other: Guideline study according OECD 404
Qualifier:
according to
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:
mean
Time point:
other: 24, 48, 72 h and 7 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h and 7 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point

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

Interpretation of results:
not irritating
Remarks:
Migrated information
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:
other: Guideline study according OECD 405
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:
mean
Time point:
other: 24, 48, 72 h, 7 days
Score:
0
Max. score:
4
Reversibility:
other: score 0 = at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h, 7 days
Score:
0
Max. score:
2
Reversibility:
other: score 0 = at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h, 7 days
Score:
0
Max. score:
3
Reversibility:
other: score 0 = at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h, 7 days
Score:
0
Max. score:
4
Reversibility:
other: score 0 = at any time point
Other effects:
A slight reddening of the cornea was visible 1 hour after application of the test substance maybe caused by mechanical irritation of the test item

The test substance is not irritating to the eyes

Interpretation of results:
not irritating
Remarks:
Migrated information
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

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).

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 classifiacion is not justified.