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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: In vitro study Performed 2015 to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. QA statement)
Species:
other: In vitro
Details on test animals or tissues and environmental conditions:
Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a
by-product from freshly slaughtered animals
Vehicle:
water
Irritation parameter:
other: In vitro score
Basis:
other: Opacity
Score:
2.8
Remarks on result:
other: In-vitro irritation score
Irritant / corrosive response data:
The test item resulted in a score of 2.8
The positive control In Vitro Irritancy Score was within the range of 27.8 to 51.0. The positive
control acceptance criterion was therefore satisfied.
The negative control gave opacity of ≤4.7 and permeability ≤0.080. The negative control
acceptance criteria were therefore satisfied.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No category. Not requiring classification to UN GHS or EU CLP.
Score 2.8
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of eye irritation endpoint:
No category. Not requiring classification to UN GHS or EU CLP.
Score 2.8

Justification for classification or non-classification