Registration Dossier

Administrative data

Description of key information

In the available studies for skin irritation/corrosion and eye irritation solvent Green 28 was not irritating/corrosive.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Two rabbits were applied 500 µl of the test substance (Macrolexgrün G) at the inner side of one of the ears. The test material was fixed by an adhesive bandage for 24 hours. After 1 and 24 hours and 2, 3, 5, 6 and 7 days the skin areas were scored for erythema and edema according to Draize.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 days
Observation period:
7 days
Number of animals:
2 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Erythema and edema scores were = 0 at any time point.
Interpretation of results:
GHS criteria not met
Conclusions:
Erythema and edema scores were = 0 at any time point.
Executive summary:

Two rabbits were applied 500 µl of the test substance (Macrolexgrün G) at the inner side of one of the ears. The test material was fixed by an adhesive bandage for 24 hours. After 1 and 24 hours and 2, 3, 5, 6 and 7 days the skin areas were scored for erythema and edema according to Draize. Erythema and edema scores were 0 at any time point. Macrolexgrün G was not irritating in this test.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Macrolexgrün G was applied to the eyes of 2 rabbits. Post observation time was 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
ca. 50 mg
Duration of treatment / exposure:
7 days (eyes were not washed).
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritating. Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours.
Executive summary:

Macrolexgrün G was applied to the eyes of 2 rabbits. Post observation time was 7 days. Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours. Macrolexgrün G was not irritating in this test.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Solvent Green 28 is not irritating/corrosive to the skin and not irritating to the eyes. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.