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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key study: EU Method B.4 (GLP study). The substance was determined to be not a skin irritant in rabbits.


Key study: EU Method B.5 (GLP study). The substance was determined to be not an eye irritant in rabbits.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
Albino
Type of coverage:
semiocclusive
Vehicle:
other: No vehicle was used.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
Yellow staining of the treated skin by the test substance was observed on day 1.

Exposure to the test substance resulted in very slight erythema in the treated skin-areas of two rabbits, which had resolved within 24 hours after exposure.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was determined to be not a skin irritant in rabbits.
Executive summary:

The study was conducted according to EU Method B.4 (GLP study). A total of 3 New Zealand White rabbits were exposed to the test substance. According to the scores obtained from erythema and edema, the substance was determined not to be a skin 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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
1 mL
Number of animals or in vitro replicates:
3
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
0.3
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
No staining of peri-ocular tissues by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not an eye irritant in rabbits.
Executive summary:

The study was conducted according to EU Method B.5 (GLP study). A total of 3 New Zealand White rabbits were exposed to the test substance. According to the scores obtained for conjunctivae (mean 24-72h score of 0 for the 3 animals), chemosis (mean 24-72h score of 0 for the 3 animals), cornea opacity (mean 24-72h score of 0 for the 3 animals) and iris (mean 24-72h score of 0 for 2 animals and 0.3 for one of them), the substance is not classified as an eye irritant

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

Additional information

Justification for classification or non-classification

Based on the available data (not skin irritant neither eye irritant), the substance does not need to be classified for irritation/corrosion according to the CLP Regulation (EC) no. 1272/2008.