Registration Dossier
Registration Dossier
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EC number: 235-462-4 | CAS number: 12236-62-3
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 DNELhas not been derived for Pigment Orange 36 because the substance did not cause relevant toxictiy in any test performed according to the information requirements.
- the substance did not cause lethal effects after administration of a single oral dose of 15000 mg/kg or in a test for acute toxicity after inhalation exposure up to the highest achievable concentration tested in rats,
- the substance is not irritating and does not have to be classified as eye or skin irritant,
- the substance does not have to be classified as skin sensitizing based on the findings in a test with guinea pigs,
- the substance caused no relevant systemic toxic effects in a subacute oral study in rats (NOAEL >= 1000 mg/kg/day,
- the substance 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 adverse effects in the above-mentioned toxicity endpoint tests indicates that the substance does not interact with living cells/tissues, and
- it is unlikely that the substance becomes systemically bioavailable due to its extremely low solubility in water and low solubility in n-octanol. The substance is not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects has been derived.
Pigment Orange 36 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is not classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments of this category after local exposure, therefore no DNEL for local effects has 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 pigments of the Acetolone group because the substances of this category did not cause relevant toxicity in any test performed according to the information requirements.
- the substance did not cause lethal effects after administration of a single oral dose of 15000 mg/kg or in a test for acute toxicity after inhalation exposure up to the highest achievable concentration tested in rats,
- the substance is not irritating and does not have to be classified as eye or skin irritant,
- the substance does not have to be classified as skin sensitizing based on the findings in a test with guinea pigs,
- the substance caused no relevant systemic toxic effects in a subacute oral study in rats (NOAEL >= 1000 mg/kg/day,
- the substance 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 adverse effects in the above-mentioned toxicity endpoint tests indicates that the substance does not interact with living cells/tissues, and
- it is unlikely that the substance becomes systemically bioavailable due to its extremely low solubility in water and low solubility in n-octanol. The substance is not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects has been derived.
Pigment Orange 36 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is not classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments of this category after local exposure, therefore no DNELs for local effects has 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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