Registration Dossier

Administrative data

Description of key information

Data provided by ECHA includes an in vivo skin irritation/corrosion test and an in vivo eye irritation/corrosion test.

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: Data migrated from NONS with permission to refer granted by ECHA.
Qualifier:
according to
Guideline:
other: 92/69/EEC
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
Based on data provided by ECHA, the test substance was not considered to be irritant or corrosive.
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: Data migrated from NONS with permission to refer granted by ECHA.
Qualifier:
according to
Guideline:
other: 92/69/EEC
GLP compliance:
yes
Specific details on test material used for the study:
Colourless liquid
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Number of animals or in vitro replicates:
3 rabbits
Irritation parameter:
other: conjuctivae (redness), chemosis, cornea and iris scores.
Basis:
animal: 1, 2 and 3.
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
This is the data extracted from NONS notification dossier and provided by ECHA
Interpretation of results:
GHS criteria not met
Conclusions:
Information provided by ECHA indicates no irritation/corrosive effects in rabbit eyes.
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

Data provided by ECHA indicates that the test substance did not illicit irritation or corrosive effects in vivo on the skin or eyes of rabbits. Accordingly this substance is not classified for skin/eye irritancy/corrosion in accordance with the CLP Regulation (1272/2008).