Registration Dossier
Registration Dossier
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EC number: 238-969-9 | CAS number: 14901-07-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.498 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 62.451 mg/m³
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.191 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 54.781 mg/kg bw/day
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - workers
Toxicokinetics
4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one (b-Ionone) in aqueous suspension with gum Arabic was administered by stomach tube to a male albino rabbit weighing about 3.0 kg at a dose of 1 g/kg/day for seven days. The total administered dose was 23 g. Urine was collected everyday during the dosing period and for 4 days after the last dose. Urine samples were extracted and analyzed forb-ionone and its metabolites. The results showed that there were five free metabolites in urine. These included 3-oxo-b-ionone, 3-oxo-b-ionol, dihydro-3-oxob-ionol, 3-hydroxy-b-ionol and unchangedb-ionone. Additionally, two glucuronides ofb-ionol were detected.Glucuronides were hydrolyzed withb-glucuronidase and were identified as the glucuronides of 3-oxo-b-ionol and dihydro-3-oxo-b-ionol.
Acute toxicity
4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one is non acute toxicity to oral, dermal and inhalation routes investigated by estimation and
Irritation / corrosion
In vivo studies of the substance show that the substance is not irritating to skin and eyes, and so the substance is not classified in any category for skin and eye as per the regulation.
Sensitisation
According to the quantitative structure activity relationship model prediction, 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one was predicted as being sensitizing to guinea pig skin. However this is a qualitative prediction assumed to be on the conservative side and therefore has not been considred high enpugh to classify the chemical as a skin sensitizer
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.621 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 31.07 mg/m³
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.54 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 27.017 mg/kg bw/day
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.383 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 109.563 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
DNEL derivation
4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one is non acute toxic to dermal oral and inhalation route, do not show irritation effect to skin and eye, is not genotoxic and is not a developmental or reproductive toxin.
In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.
In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.
A standard approach to deriving DNEL values would be to use the repeated dose toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the LOEL of124.28 mg/m3bw/d in inhalation category.
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