Registration Dossier
Registration Dossier
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EC number: 204-493-5 | CAS number: 121-69-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.406 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: NOEL
- Value:
- 127.725 mg/m³
- AF for intraspecies differences:
- 5
- Justification:
- worker default
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:
- 2.988 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: NOEL
- Value:
- 112.04 mg/kg bw/day
- AF for intraspecies differences:
- 5
- Justification:
- worker default
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
Toxicokinetics
There is little information available on the complete toxico-kinetics (absorption, distribution, metabilism and excretion) of the target chemicalN,N-dimethylaniline. The chemical is though known to have effects on the blood count and haematopoietic system of human beings that have been exposed to the chemical.
However considering the various metabolites that are formed with N,N-dimethylaniline, its ready bio-degradability in water and low bio-accumulation factor (BCF) of 16, N,N-dimethylaniline is likely to exhibit low bio-accumulation potential upon exposure to low dose levels
Acute toxicity
N,N-dimethylaniline is of moderately acute toxicity by oral and dermal route investigated, the acute LD50 values of the substance for the routes indicate that the substance is categorized in class 3 as per the CLP regulation criteria.
Irritation / corrosion
In vivo studies of N,N-dimethylaniline show that the substance is a non - irritating to skin and also do not have major irritation effect to eyes, and so the substance is not classified in skin irritation category and also no eye irritation according to current criteria.
Sensitisation
No evidence of skin sensitisation was noted in a estimation study for N,N-dimethylaniline.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.847 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: NOEL
- Value:
- 63.545 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:
- 0.737 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: NOEL
- Value:
- 55.257 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- general population default
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:
- 1.474 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: NOEL
- Value:
- 110.513 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- general population default
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
DNEL derivation
N,N-dimethylaniline is of moderate acute toxic to oral and dermal, is not irritant 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 254.18 mg/m3 bw/d in inhalation category.
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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