Registration Dossier
Registration Dossier
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EC number: 412-550-2 | CAS number: 85776-14-3 GRAPHTOL ORANGE 3RT; PERMANENT ORANGE 2 RLD; PERMANENT ORANGE 3 RTN
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 74 because the substances or substances with a similar structure did not cause relevant toxictiy in any test performed according to the information requirements.
- the LD50 of Pigment Orange 74 is above 2000 mg/kg bw after single oral or dermal administration and thus does not have to be classified regarding acute toxicity,
- Pigment Orange 74 is neither irritating nor sensitizing to skin and does not have to be classified as eye or skin irritant, or as skin sensitizing, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues,
- Pigment Orange 74 didn’t cause systemic toxic effects in a 28-day oral gavage study in rats (NOAEL: >=1000 mg/kg/day) and there was no evidence of absorption or accumulation of the substance after repeated exposure,
- Pigments with a similar chemical structure (Pigment Red 022 and Pigment Red 170) caused no relevant systemic toxic effects in parental animals and offspring, and no effects on fertility or development in a Reproduction/Developmental Toxicity Screening test and a Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening in rats (NOAEL >= 1000 mg/kg/day).
- Pigment Orange 74 is a chemically unreactive substance. This property in combination with its extremely low solubility in water and n-octanol suggests that it is unlikely that Pigment Orange 74 will be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
Pigment Orange 74 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 74 because the substances or substances with a similar structure did not cause relevant toxictiy in any test performed according to the information requirements.
- the LD50 of Pigment Orange 74 is above 2000 mg/kg bw after single oral or dermal administration and thus does not have to be classified regarding acute toxicity,
- Pigment Orange 74 is neither irritating nor sensitizing to skin and does not have to be classified as eye or skin irritant, or as skin sensitizing, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues,
- Pigment Orange 74 didn’t cause systemic toxic effects in a 28-day oral gavage study in rats (NOAEL: >=1000 mg/kg/day) and there was no evidence of absorption or accumulation of the substance after repeated exposure,
- Pigments with a similar chemical structure (Pigment Red 022 and Pigment Red 170) caused no relevant systemic toxic effects in parental animals and offspring, and no effects on fertility or development in a Reproduction/Developmental Toxicity Screening test and a Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening in rats (NOAEL >= 1000 mg/kg/day).
- Pigment Orange 74 is a chemically unreactive substance. This property in combination with its extremely low solubility in water and n-octanol suggests that it is unlikely that Pigment Orange 74 will be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
Pigment Orange 74 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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