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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: New Zealand
Type of coverage:
occlusive
Amount / concentration applied:
500 mg in 1.2 ml polyethylene glycol 400 (approx. 40%)
Duration of treatment / exposure:
24h
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Score:
< 2
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: no further data available
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)

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)
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: New Zealand
Vehicle:
other: polyethylene glycol
Amount / concentration applied:
100 mg substance in 0.4 ml polyethylene glycol (approx. 25%)
Duration of treatment / exposure:
eyes were rinsed after 24h
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: slightly irritating
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

In view of the experimental results on skin (OECD TG404) and eye (OECD TG405) the substance must not be classified