1-(4-methyl-2-nitrophenylazo)-2-naphthol

Endpoint summary

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

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

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Remarks:

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

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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.

Clinical signs:

other:

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.