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Description of key information

Valid studies with Reinblau BLW (CAS 32724-62-2) for skin and eye irritation are available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented
Principles of method if other than guideline:
500 µl of the test substance was applied to the intact inner surface of one ear per animal; exposure time was 24 hours. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2 animals
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Other effects:
no corrosive effects evident

Score = 0 at any time point (1h, 24h, 72h, 5d, 6d and 7d).


Therefore Macrolex Blau RR is not irritating to the skin

Interpretation of results:
not irritating
Executive summary:

500 µl of the test substance was applied to the intact inner surface of one ear per rabbit; exposure time was 24 hours. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.

No erythema and no edema was visible. Therefore Macrolex Blau RR is not irritating to the skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
not determinable
Remarks:
determination of the erythema score was not possible due to substance induced coloration of the skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
not determinable
Remarks:
determination of the erythema score was not possible due to substance induced coloration of the skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
not determinable
Remarks:
determination of the erythema score was not possible due to substance induced coloration of the skin
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

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
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:
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

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

Interpretation of results:
not irritating
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

Skin irritation


In a study performed according OECD 404 (Schreiber, 1982) 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. 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).


In another study (Thyssen, 1975), 500 µL of the test substance was applied on the skin of 2 rabbits for 24 hours. Erythema and edema were scored according to Draize No erythema nor edema were observed. Scores were 0 at any time point (1, 24, 72 h, 6 and 7d).


 


Eye irritation


In a valid study according OECD 405 (Schreiber, 1982) 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.


 

Justification for classification or non-classification

Due to the results of the skin irritation/corrosion and eye irration study a classifiacion is not justified.