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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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Unknow purity
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
vegetable oil
Remarks:
sesame oil
Doses:
2 times 5000 mg/kg bw were dosed to each rat via gavage within 1 hour
No. of animals per sex per dose:
10
Sex:
female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 10,000 mg/kg
Executive summary:

No rats died during the study. Passivity and diarrhea were observed after the dosing. Faeces and urine were stained red. The discoloration of the feces was observed up to 7 days after application. The occurrence of reddish skin discoloration after 24 hours was occasionally observed up to the end of study.

The behavior and body weight development were normal in the 14-day follow-up period.

The sections of the killed animals after the experiments were macroscopically inconspicuous

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
arachis oil
Remarks:
BP
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

Mortality.There were no deaths.

Clinical Observations.Red/brown staining of the snout was noted in one male two hours after dosing. There were no other signs of systemic toxicity noted.

Dermal Irritation.Crust formation was noted at the test site of one female animal five and six days after dosing. No other signs of dermal irritation were noted.

Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy.No abnormalities were noted at necropsy

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity:

Acute toxicity after single oral application was tested in male and female rats and mice, which received 10,000 mg/kg bw . No animals in these studies died. The LD50 value for acute oral toxicity is >10,000 mg/kg bw.

Acute dermal toxicity:

A Study was conducted with C.I. Pigment Orange 5 in rats. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw.

Acute inhalation toxicity:

Study was waived; substance is not classified for this endpoint. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust.

Justification for selection of acute toxicity – oral endpoint
No acute oral toxicity has been observed in rats and mice. Study with the highest reliability was selected.

Justification for classification or non-classification

Due to the findings described above (LD50 oral in rats >10,000 mg/kg bw) Pigment Red 3 not to be classified as acute orally toxic according to the criteria laid down in the EU Dangerous Substances directive (67/548/) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

It can reasonably be deduced that Pigment Red 3 does not exert systemic toxic effects after dermal application and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because

- Pigment Red 3did not cause lethal effects after administration of a single oral dose of up to 10,000 mg/kg in rats and mice,

- Pigment Red 3does not have to be classified as skin irritating, and

- it is unlikely that Pigment Red 3 becomes systemically bioavailable after skin contact due to its extremely low solubility in water and n-octanol.

Therefore, testing is not necessary to reach a scientific conclusion on classification.

It can reasonably be deduced that Pigment Red 3 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 the EU Dangerous Substances Directive (67/548/) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because

- Pigment Red 3 did not cause lethal effects after administration of a single oral dose of up to 10,000 mg/kg in rats,

- Pigment Red 3 does not have to be classified as skin irritating, and

- it is unlikely that Pigment Red 3 becomes systemically bioavailable after inhalation due to its extremely low solubility in water and n-octanol.

Therefore, it is concluded that Pigment Red 3, when aerosolized, is an inert dust and that testing is not necessary to reach a scientific conclusion on classification.

Furthermore, Pigment Red 3 does not have to be classified for specific target organ toxicity – single exposure according to Regulation (EC) No 1272/2008, as no specific toxic effects were observed after acute exposure.