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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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#001-4.1.11-01
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Vehicle:
polyethylene glycol
Remarks:
400
Doses:
5000 mg / kg bw
No. of animals per sex per dose:
5 males
5 females
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Clinical signs:
Unspecific intoxication symptoms reversible within 3 days (red colouration of the limps).
Gross pathology:
No morphological changes observed at the post mortem examination.

 sex  dose (mg / kg bw)  number of animals number of deaths 
 M  5000  5  0
 F  5000  5  0
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not subject to classification and labelling
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
SNIF#001-4.1.11-01

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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#001-4.1.30-01
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Remarks:
400
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males
5 females
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
The treated skin was redly coloured after treatment.
No toxic symptoms could be observed.
Gross pathology:
No substance related damage in organs was found during the postmortem examination.

sex

 dose (mg/kg bw)  numbers of animals  number of deaths
 M  2000  5  0
 F  2000  5  0
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not subject to classification and labelling.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
SNIF#001-4.1.30-01

Additional information

Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for selection of acute toxicity – inhalation endpoint
Study was waived and classification for this endpoint is considered unwarranted. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust.

Justification for selection of acute toxicity – dermal endpoint
only one study available

Justification for classification or non-classification

Due to the findings described above (LD50 oral in rats > 5000 mg/kg bw, LD50 dermal in rats > 2000 mg/kg bw) Pigment Red 254 has not to be classified as acute orally and dermally toxic according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008.

It can reasonably be deduced that Pigment Red 254 does not exert systemic toxic effects after acute inhalation exposure 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 did not cause lethal effects after administration of a single oral dose of up to 5000 mg/kg bw in rats

- Pigment Red 254 did not cause lethal effects after administration of a single dermal dose up to 2000 mg/Kg bw in rats

- Pigment Red 254 does not have to be classified as skin or eye irritating or as skin sensitzing, and

- it is unlikely that Pigment Red 254 becomes systemically bioavailable after inhalation due to its extremely low solubility in water and n-octanol.

Therefore, it is concluded that Pigment Red 254, when aerosolized, is an inert dust and that testing is not necessary to reach the scientific conclusion that classification is not warrantable.