Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Amount / concentration applied:
0.5 mL/site
Duration of treatment / exposure:
4 hrs
Observation period:
1, 24, 48, 72 hrs after application, observation was continued for 14 days after the last patch was removed.
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
other: eschar
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Other effects:
No treatment-related clinical signs, body weight changes, dead animals, or abnormal skin reaction were observed.
Interpretation of results:
GHS criteria not met
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
1, 24, 48, 72 hrs after the application
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal:
Remarks:
#1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal:
Remarks:
#1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal:
Remarks:
#1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal:
Remarks:
#1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Other effects:
No test item-related clinical signs, body weight changes, dead animals or abnormal eye reaction were observed.
Interpretation of results:
GHS criteria not met
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