Registration Dossier
Registration Dossier
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EC number: 241-866-1 | CAS number: 17927-72-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.75 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 1 065.028 mg/m³
- AF for intraspecies differences:
- 5
- Justification:
- worker
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:
- DNEL (Derived No Effect Level)
- Value:
- 10.067 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 604.046 mg/kg bw/day
- AF for intraspecies differences:
- 5
- Justification:
- worker
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:
- medium hazard (no threshold derived)
Additional information - workers
Acute toxicity
The acute oral median lethal dose (LD50) of phenylacetic acid in Rodent - rat was found to be 2250 mg/kg of body weight. Acute oral toxicity of phenylacetic acid to Rodent-rat by oral route indicates that phenylacetic acid does not exhibits acute toxicity by the oral route. Similarly, inhalation toxicity (LC50 value) of phenylacetic acid vapours was examined for 4 hrs. and the value suggests that phenylacetic acid is non toxic to mouse by the inhalation route. The acute dermal median lethal dose (LD50) of phenylacetic acid in Rodent - rabbit was found to be >5000 mg/kg of body weight. Acute dermal toxicity of phenylacetic acid to Rodent - rabbit by dermal route indicates that phenylacetic acid does not exhibits acute toxicity by the dermal route.
Irritation / corrosion
In vivo studies of the substance show that the substance is irritating to skin and eyes, and so the substance is classified in category 2 for skin andeye irritation according to current criteria.
Sensitisation
According to the quantitative structure activity relationship model prediction, phenylacetic acid was predicted as not being sensitizing to human skin.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.377 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 525.257 mg/m³
- AF for intraspecies differences:
- 10
- Justification:
- general population
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:
- DNEL (Derived No Effect Level)
- Value:
- 5.034 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 604.046 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- general population
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:
- DNEL (Derived No Effect Level)
- Value:
- 2.517 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 302.023 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- general population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNEL derivation
Phenylacetic acid is non acute toxic to oral, dermal and inhalation route, shows 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 NOEL of 1208.092 mg/kg bw/d in oral category.
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