Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
70 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Commission Directive 2006/15/EC established a list of indicative occupational exposure limit (IOEL) values
Dose descriptor starting point:
NOAEL
Value:
342 mg/m³
Explanation for the modification of the dose descriptor starting point:

Expert review and IOEL method

Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
102 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: UK HSE STEL: 2011
Explanation for the modification of the dose descriptor starting point:

Reliable animal data indicate that acetonitrile is not a skin irritant, is not acutely toxic by the dermal route, and is not a skin sensitizer. Local effects are therefore unlikely. However a STEL of 60 ppm (102 mg/m3) is set UK HSE EH40/2005 Workplace exposure limits, 2nd Edition 2011. This may be reflective of early US ACGIH published values for a STEL and is reasonably assumed to be protective of workers for short term exposure.

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
70 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Commission Directive 2006/15/EC established a list of indicative occupational exposure limit (IOEL) values
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
102 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
20 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Commission Directive 2006/15/EC established a list of indicative occupational exposure limit (IOEL) values for 8 h inhalation exposure
Dose descriptor starting point:
other: Commission Directive 2006/15/EC established a list of indicative occupational exposure limit (IOEL) values for 8 h inhalation exposure
Value:
70 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The IOEL TWA converted to mg/kg dose over 8 h, breathing 10 m3, then adjusted for 50% dermal absorption

AF for dose response relationship:
1
Justification:
IOEL converted
AF for differences in duration of exposure:
1
Justification:
Chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Worker IOEL converted
AF for other interspecies differences:
1
Justification:
IOEL conversion
AF for intraspecies differences:
1
Justification:
Worker IOEL converted
AF for the quality of the whole database:
1
Justification:
Complete
AF for remaining uncertainties:
1
Justification:
Worker IOEL converted
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.4 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
Dose descriptor starting point:
NOAEC
Value:
340 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
60 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEC in a chronic mouse study is used to calculate a modified dose descriptor. In the chronic mouse study, exposure was for six hours a day for five days a week. To convert this to 24 hour exposure for the general popluation, the NOAEC needs to be corrected by a factor of 0.25 (6/24) and 0.714 (5/7).

The modified dose descriptor is therefore 336 mg/m^3 * 0.25 * 0.714, which is 60 mg/m^3

AF for dose response relationship:
1
Justification:
Default value: A modified NOAEC from a chronic mouse study is used as the starting point.
AF for differences in duration of exposure:
1
Justification:
Since the repeated dose study was a chronic study, no assessment factor for duration of exposure is required.
AF for interspecies differences (allometric scaling):
1
Justification:
This is not required for inhalation as this is accounted for in the calculation
AF for other interspecies differences:
2.5
Justification:
Default value for toxiokinetic and toxicodynamics interspecies differences.
AF for intraspecies differences:
10
Justification:
Default value for the general population.
AF for the quality of the whole database:
1
Justification:
Default value: good quality database
AF for remaining uncertainties:
1
Justification:
Default for remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
22 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: Acute Exposure Guidance levels published by EPA.
Overall assessment factor (AF):
3
Dose descriptor starting point:
NOAEC
Value:
66 mg/m³
Modified dose descriptor starting point:
other: Human volunteer study
Explanation for the modification of the dose descriptor starting point:

Not required as taken from human volunteer study (4 h exposure)

AF for dose response relationship:
1
Justification:
Based on human volunteers
AF for interspecies differences (allometric scaling):
1
Justification:
based on human volunteers
AF for other interspecies differences:
1
Justification:
Study conducted in humans; no assessment factor required.
AF for intraspecies differences:
1
Justification:
Based on human volunteers
AF for the quality of the whole database:
1
Justification:
Human exeperience and chronic inhalation studies in animals
AF for remaining uncertainties:
3
Justification:
Limited number of subjects in trial

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
22 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Acute Exposure Guidance levels 2 published by US EPA.
Overall assessment factor (AF):
3
Dose descriptor starting point:
NOAEC
Value:
66 mg/m³
AF for interspecies differences (allometric scaling):
1
Justification:
Human volunteers
AF for other interspecies differences:
1
Justification:
Study conducted in humans; no assessment factor required.
AF for intraspecies differences:
1
Justification:
study in human volunteers
AF for the quality of the whole database:
1
Justification:
Human volunteers and chronic rodent inhaltion values
AF for remaining uncertainties:
3
Justification:
Limited number of subjects in trial

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.2 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
Dose descriptor starting point:
NOAEC
Value:
342 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEC from chronic mouse inhaltion exposure study, converted to equivalent rat exposure level for 24 h over 7 days per week.

AF for dose response relationship:
1
Justification:
inhalation
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
as guidance
AF for other interspecies differences:
2.5
Justification:
standard residual
AF for intraspecies differences:
10
Justification:
Standard for general population
AF for the quality of the whole database:
1
Justification:
Complete
AF for remaining uncertainties:
1
Justification:
No further AF required; assumed 100% obsorption
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:
0.4 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
Dose descriptor starting point:
NOAEC
Value:
70 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The mouse 200 ppm NOAEC (6 h per day, 5 days per week) was converted to a continuous exposure. This was multiplied by 1.15 m3/kg bw. This was then divided by 7, to convert from the mouse to human.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA values used
AF for other interspecies differences:
2.5
Justification:
ECHA values
AF for intraspecies differences:
10
Justification:
Genral population ECHA default
AF for the quality of the whole database:
1
Justification:
Full data base
AF for remaining uncertainties:
1
Justification:
Full data base
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
500
Dose descriptor starting point:
other: LD10
Value:
300 mg/kg bw/day
AF for dose response relationship:
10
Justification:
The mouse LD 10 was divided by 10 to estimate the NOAEL
AF for other interspecies differences:
10
AF for intraspecies differences:
5

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

No uses which expose the genral population to acetonitrile are supported.