Registration Dossier
Registration Dossier
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EC number: 214-269-9 | CAS number: 1118-84-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.521 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):
- 37.5
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 357.044 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:
- 8.352 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):
- 37.5
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 313.197 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
Allyl acetoacetate shall exhibit acute toxicity by the oral and dermal route in the acute category 3. It is not toxic by the inhalation route based upon the available data. It shows skin irritation potential but is not likely to cause eye irritation. Allyl acetoacetate was found to be non sensitizing to skin.
The chemical does not demonstrate genetic toxicity potential. Within the doses reported in the available studies, allyl acetoacetate did not exhibit reproductive toxicity studies.
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 710.5355 mg/kg body weight by inhalation route.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.368 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):
- 75
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 177.634 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:
- 2.06 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):
- 75
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 154.464 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:
- 16.704 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):
- 75
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 626.393 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
Acute toxicity
Oral
The acute oral median lethal dose (LD50) of allyl acetoacetate in Peromyscus maniculatus was found to be 562.7319 mg/kg of body weight.This classifies the chemical as being toxic in the toxicity category IV as per the CLP criteria. The second study from a read-across also indicates the LD50 value for oral exposure of methyl acetoacetate to be between 1250-3500 mg/kg in the various species (rat,mouse and rabbit ) used in the study. The third study though indicates an LD50 value that classfies the chemical in acute oral toxicity category 3. Using a weight of evidence, it was concluded that allyl acetoacetate shall exhibit acute oral toxicity in category 4
Inhalation
The 8h acute inhalation median lethal concentration (LC50) of allyl acetoacetate in rat was estimated to be 472.3419 mg/L . This value indicates that allyl acetoacetate does not exhibit acute toxicity by the inhalation route. The weight of evidence studies can be summarised as below which indicates that even in mouse as well as in rat using the analogue chemical, toxicity via the inhalation route is not expected.
Dermal
The LD50 value of the analogue chemical substance allyl butyrate is found to be 530 mg/kg body weight in rabbit. This classifies the chemical as being toxic in the toxicity category III as per the CLP criteria.
Irritation / corrosion
The substance allyl acetoacetate was found to be slightly irritating to skin whereas it was found to be non-irritating to the eye of rabbit.
Sensitisation
According to the quantitative structure activity relationship model prediction, allyl acetoacetate was predicted as not being sensitizing to skin.
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