Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Information is available from the full public report issued by the Australian competent authority (NICNAS); it is therefore assumed to provide reliable 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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
water
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48,72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
other: all 3 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Erythema was seen in 1/3 animals at 24h, but had resolved at 48h
Interpretation of results:
not irritating
Remarks:
Migrated information
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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
water
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
Investigation with fluorescein was performed.
Irritation parameter:
conjunctivae score
Basis:
other: all three animals
Time point:
other: 24, 48 and 72h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48h

Mean Score (mean of 24, 48 and 72h) Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period
Findings Animal No.1  Animal No.2  Animal No.2
Conjunctiva: redness 1 1 1 2 48 h 0
Conjunctiva: chemosis 0 0.33 0.33 1 24 h 0
Conjunctiva:discharge** - - - -  not applicable
Corneal opacity 0 0 0 0  not applicable 0
Iris 0 0 0 0 not applicable 0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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