Registration Dossier
Registration Dossier
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EC number: 268-734-6 | CAS number: 68134-22-5
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 pigments of the Acetolone Pigments group because the substances did not cause relevant toxictiy in any test performed according to the information requirements.
- the substances did not cause lethal effects after administration of a single oral dose of >= 2000 mg/kg or in tests for acute toxicity after inhalation exposure up to the highest achievable concentration tested (mean concentration > 0.7 g/cubicmeter air) in rats,
- the substances are not irritating and do not have to be classified as eye or skin irritants,
- the substances do not have to be classified as skin sensitizing based on the findings in several LLNAs and tests with guinea pigs,
- the substances caused no relevant systemic toxic effects in several subacute oral studies in rats (NOAEL >= 1000 mg/kg/day, or in case of one study NOAEL 500 mg/kg bw (i.e. higest dose tested))
- the substances caused no systemic toxic effects, no effects on fertility or development in a Reproduction / Developmental Toxicity Screening Test (OECD Guideline 421; NOAEL 1000 mg/kg bw/day),
- the 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 adverse effects in the above-mentioned toxicity endpoint tests indicates that the substances do not interact with living cells/tissues, and
- it is unlikely that the substances become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. The substances are not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
Acetolone Pigments do not cause irritation, corrosion or sensitization. They are considered unlikely to become bioavailable in the skin and are considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments 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 pigments of the Acetolone group because the substances did not cause relevant toxicity in any test performed according to the information requirements.
- the substances did not cause lethal effects after administration of a single oral dose of >= 2000 mg/kg or in tests for acute toxicity after inhalation exposure up to the highest concentration tested (mean concentration > 0.7 g/cubicmeter air) in rats,
- the substances are not irritating and do not have to be classified as eye or skin irritants,
- the substances do not have to be classified as skin sensitizing based on the findings in several LLNAs and tests with guinea pigs,
- the substances caused no relevant systemic toxic effects in several subacute oral studies in rats (NOAEL >= 1000 mg/kg/day, or in case of one study NOAEL 500 mg/kg bw (i.e. higest dose tested))
- the substances caused no systemic toxic effects, no effects on fertility or development in a Reproduction / Developmental Toxicity Screening Test (OECD Guideline 421; NOAEL 1000 mg/kg bw/day),
- the 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 substances do not interact with living cells/tissues, and
- it is unlikely that the substances become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. The substances are not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
Acetolone Pigments do not cause irritation, corrosion or sensitization. They are considered unlikely to become bioavailable in the skin and are considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments 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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