Registration Dossier

Administrative data

Description of key information

Repeated oral toxicity:
An OECD test guideline (OECD 407) Repeated Dose Toxicity Study was performed with Pigment Red 254. Groups of 5 male and 5 female Wistar rats/dose received different doses up to 1000 mg/kg bw by daily gavage for 28 days. No toxicologically significant changes were noted in any of the parameters investigated in this study. A No Observed Adverse Effect Level (NOAEL) for the test item of 1000 mg/kg/day was established.
Repeated dermal toxicity:
The dermal route was waived. The substance is considered not to exert adverse effects.
Repeated inhalation toxicity:
The inhalation route was waived. The substance is considered not to exert adverse effects.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: reliability not verifiable
Rationale for reliability incl. deficiencies:
other: no data provided
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
GLP compliance:
not specified
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
400
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily
Remarks:
Doses / Concentrations:

Basis:
no data
No. of animals per sex per dose:
5 males / 5 females per dose
Control animals:
not specified
Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Details on results:
clinical observation:
Red discolored extremities were observed in the animals of the high dose group (1000 mg/kg) starting with day 21.

clinical chemistry/haematology:
No changes of toxicological significance at termination of the treatment.

necropsy findings/histopathology:
There was no evidence of histopatological findings resulting from treatment with the substance.

Two female animals died spontaneously on day 17 of the test, due to a possible intubation error.
Dose descriptor:
NOEL
Effect level:
1 000 other: mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects up to the highest dose tested
Critical effects observed:
not specified
Conclusions:
Based on the results of this OECD 407 study, the NOAEL was considered to be 1000 mg/kg body weight/day.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Quality of whole database:
Data from Corrigendum INQ-C-0000001809-65-1

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study available

Justification for classification or non-classification

Pigment Red 254 does not have to be classified regarding systemic and target organ toxicity after repeated oral exposure according to the criteria, laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008, because:

  • Pigment Red 254 caused no relevant systemic effects and revealed a NOAEL of 1000 mg/kg/day in a 28 day Repeated Dose Toxicity Study after oral application.

 

It can reasonably be deduced that Pigment Red 254 does not exert systemic toxic effects after repeated dermal application 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 and that testing is not scientifically necessary, because:

  • Pigment Red 254 caused no relevant systemic effects and revealed a NOAEL of 1000 mg/kg/day in a 28 day Repeated Dose Toxicity Study after oral application
  • it is unlikely that Pigment Red 254 becomes systemically bioavailable to a relevant extend after dermal exposure due to its extremely low solubility in water and n-octanol,
  • the repeated dose toxicity after dermal application is not considered to be higher than after oral administration,
  • testing for acute dermal toxicity revealed no signs of bioavailability or toxicity.
  • Pigment Red 254 does not have to be classified as skin sensitizing or as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.

 

It can reasonably be deduced that Pigment Red 254 does not exert systemic toxic effects after repeated 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 and that testing is not scientifically necessary, because:

  • Pigment Red 254 caused no relevant systemic effects and revealed a NOAEL of 1000 mg/kg/day in a 28 day Repeated Dose Toxicity Study after oral application
  • it is unlikely that Pigment Red 254 becomes systemically bioavailable to a relevant extend after inhalation due to its extremely low solubility in water and in n-octanol,
  • Pigment Red 254 does not have to be classified as skin sensitizing or as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and in n-octanol largely prevent interaction with living cells and tissues,
  • Pigment Red 254, when aerosolized in respirable form, is likely to behave like an inert dust.