Registration Dossier
Registration Dossier
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EC number: 239-898-6 | CAS number: 15793-73-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Worker DNELs have not been derived for Pigment Orange 34 because Pigment Orange 34 and structure analogues did not cause relevant toxictiy in any test performed according to the information requirements.
- the considered substances did not cause lethal effects after administration of a single oral dose of >= 2000 mg/kg or a single dermal dose of 2000 mg/kg in rats,
- the substances are not irritating and do not have to be classified as eye or skin irritants,
- the considered substances caused no relevant systemic toxic effects in several subacute studies and a subchronic oral study in rats (NOAEL 500 mg/kg/day, which was the highest dose tested),
- the considered substances caused no systemic toxic effects, no effects on fertility or development in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422; NOAEL 1000 mg/kg bw/day),
- the absence of effects in the above-mentioned toxicity endpoint tests indicates that the considered substances do not interact with living cells/tissues, and
- it is unlikely that the considered substances become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. The considered substances are not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
Pigment Orange 34 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected after local exposure, therefore no DNELs for local effects have been derived.
Apart from that, relevant occupational exposure limits for inert dusts should be applied.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNELs for the general population have not been derived for Pigment Orange 34 because Pigment Orange 34 and structure analogues did not cause relevant toxictiy in any test performed according to the information requirements.
- the considered substances did not cause lethal effects after administration of a single oral dose of >= 2000 mg/kg or a single dermal dose of 2000 mg/kg in rats,
- the considered substances are not irritating and do not have to be classified as eye or skin irritants,
- the considered substances caused no relevant systemic toxic effects in several subacute studies and a subchronic oral study in rats (NOAEL 500 mg/kg/day, which was the highest dose tested),
- the considered substances caused no systemic toxic effects, no effects on fertility or development in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422; NOAEL 1000 mg/kg bw/day),
- the absence of effects in the above-mentioned toxicity endpoint tests indicates that the considered substances do not interact with living cells/tissues, and
- it is unlikely that the considered substances become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. The considered substances are not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
Pigment Orange 34 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected after local exposure, therefore no DNELs for local effects have been derived.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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