Registration Dossier

Administrative data

Description of key information

Skin irritation:
According to the results of a skin irritation test Pigment Red 254 can be regarded as not skin irritating.
Eye irritation:
According to the results of a eye irritation test (Annex V, B.5) Pigment Red 254 can be regarded as not eye irritating.
Respiratory tract:
Based on available data the substance is considered likely to behave like an inert dust. Consequently the substance is considered not to exert any local irritative effects. Therefore, it is concluded, that testing is not necessary to reach the scientific conclusion that classification is not warrantable.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
Remarks:
other: No information provided
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: reliability not verifiable
Rationale for reliability incl. deficiencies:
other: no detailed information in SNIF#001-4.1.50-01
Qualifier:
according to
Guideline:
other: Annex V, B.4.
GLP compliance:
yes
Species:
other: no information provided
Strain:
other: no information provided
Irritation parameter:
erythema score
Basis:
other: no data provided
Time point:
other: no data provided
Score:
>= 0
Remarks on result:
other: mean scores >=0 but below the threshold for classification
Irritation parameter:
edema score
Basis:
other: no data provided
Time point:
other: not data provided
Score:
>= 0
Remarks on result:
other: mean scores >=0 but below the threshold for classification
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

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 skin irritation / corrosion endpoint:
only one study available

Justification for selection of eye irritation endpoint:
only one study available

Justification for classification or non-classification

Pigment Red 254 has been tested for skin irritative properties and does not have to be classified as skin irritating according to Directive 67/548/EEC and Regulation (EU) No 1272/2008.

 

Pigment Red 254 has been tested for eye irritative properties and does not have to be classified as skin irritating according to Directive 67/548/EEC and Regulation (EU) No 1272/2008.

 

It can reasonably be deduced that Pigment Red 254 does not cause respiratory tract irritation and thus does not have to be classified according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008, because Pigment Red 254 has not to be classified as skin or eye irritating. Moreover, Pigment Red 254, in the unlikely event of being inhaled as a dust, is considered not to cause more severe effects than an inert dust, because its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.