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Administrative data

Description of key information

Valid studies with Reinblau BLW (CAS 32724-62-2) for skin and eye irritation are available. The results were supported by additional skin and eye irritation studies conducted with Reinblau RLW (CAS 41611-76-1).

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
Principles of method if other than guideline:
500 µl of Macrolex blau RR fl. was applied on a 2.5 x 2.5 cm² area at the shaved trunk of 3 rabbits and fixed semi-occlusively for 24 h. Reading was carried out 1, 24, 48, 72 h and 8 d the application.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 animals
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
8
Reversibility:
other: score = 0 at any time point if reading was possible

At 1, 24, 48, 72 h a determination of the erythema score was not possible due to substance induced coloration of the skin. At 8 d the score was 0.

Edema score was 0 at any time point (1, 24, 48, 72 h, and 8 d)

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

500 µl of Macrolex Blau RR fl. was applied on a 2.5 x 2.5 cm² area at the shaved trunk of 3 rabbits and fixed semi-occlusively for 24 h. Reading was carried out 1, 24, 48, 72 h and 8 d after the application.

At 1, 24, 48, 72 h a determination of the erythema score was not possible due to substance induced coloration of the skin. At 8 d the score was 0. Edema score was 0 at any time point (1, 24, 48, 72 h, and 8 d). The primary irritation index is = 0.

The test substance is classified as non-irritant.

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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
100 µl Macrolex Blau RR fl. was applied into the conjunctival sac of the right eye of 3 rabbits. Reading was carried out 1, 24, 48 and 72 h, and 8 d afterthe application of the test substance.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 rabbits
Irritation parameter:
other: primary irritation index
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
110
Reversibility:
other: not applicable - score = 0 at any time point

Macrolex RR fl. produced a primary irritation value of 0 concerning irritation in mucous membrane on the eye

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

100 µl Macrolex Blau RR fl. was applied into the conjunctival sac of the right eye of 3 rabbits. Reading was carried out 1, 24, 48 and 72 h, and 8 d afterthe application of the test substance.

Macrolex RR fl. produced a primary irritation value of 0 concerning irritation in mucous membrane on the eye. Thus, 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

In a valid study according OECD 404 500 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.

In a valid study according OECD 405 100 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.

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.

The results were supported by skin and eye irritation studies on Reinblau RLW (CAS 41611 -76 -1).

500 µl of the test substance Reinblau RLW 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.