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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
11.76 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
881.72 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalatory study available - Oral read across study used for route to route extrapolation
AF for dose response relationship:
1
Justification:
An assessment factor of 1 is applicable when the starting point is a NOAEL/NOEL.
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute to chronic studies
AF for interspecies differences (allometric scaling):
1
Justification:
Route-route concentration. No allometric scaling required as differences in allometry were considered in the conversion from oral to inhalation starting point
AF for other interspecies differences:
2.5
Justification:
Default AF for remaining differences
AF for intraspecies differences:
5
Justification:
Default AF for worker population
AF for the quality of the whole database:
1
Justification:
Data available on target substance; relevant studies conducted to GLP and of reliability 1
AF for remaining uncertainties:
1
Justification:
None identified
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:
3.33 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study available - Oral read across study used for route to route extrapolation
AF for dose response relationship:
1
Justification:
An assessment factor of 1 is applicable whenthe starting point is a NOAEL/NOEL
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute to chronic studies
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for allometric scaling for rats
AF for other interspecies differences:
2.5
Justification:
Default AF for remaining differences
AF for intraspecies differences:
5
Justification:
Default AF for worker population
AF for the quality of the whole database:
1
Justification:
Data available on target substance; relevant studies conducted to GLP and of reliability 1
AF for remaining uncertainties:
1
Justification:
None identified
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

The substance is not classified for human health.

An acute inhalation study showed no significant toxicity and local effects are not considered to be a hazard as the substance is not a skin irritant or a skin sensitiser.

Long-term systemic DNELS have been derived for inhalation and dermal routes.

 

Worker inhalation systemic effects long-term exposure DNEL:

A DNEL has been derived for long-term systemic effects by the inhalation route. The DNEL is derived by route-to-route extrapolation from an oral NO(A)EL of 1000 mg/kg bw/day from a 28-day repeated dose oral toxicity study.

A modification of the dose descriptor starting point (oral to inhalation) was conducted. It was assumed that the oral absorption rate is 50 % of that of the inhalation absorption.

The corrected 8 hour inhalation NOAEC was 881.72 mg/m3.

The corrected dose descriptor (NOAEC) for inhalation was calculated in accordance with the EHCA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.

Default parameters for rats and humans (for 8 hour exposure) were used for the modification of starting point under the allometric scaling principle. Appropriate assessment factors were then applied to give an overall assessment factor of 75. These factors were used to derive a DNEL of 11.76 mg/m3.

 

Worker inhalation systemic effects acute exposure DNEL:

No hazard was identified. The material is not classified for acute effects therefore derivation of an acute DNEL is not required.

 

Worker inhalation local effects long-term exposure DNEL:

No hazard was identified. No DNEL has been derived for long-term inhalation local effects, as no long-term inhalation study is available. However, the substance showed no significant toxicity in the acute study and significant local effects from repeated exposure are not anticipated.

 

Worker inhalation local effects acute exposure DNEL:

No hazard was identified. The material is not classified for acute systemic effects therefore derivation of acute DNEL is not required.

 

Worker dermal systemic effects long-term exposure DNEL:

A DNEL has been derived for long-term systemic effects by the dermal route. The DNEL is derived by route-to-route extrapolation from an oral NO(A)EL of 1000 mg/kg bw/day from a 28-day repeated dose oral toxicity study.

A modification of the dose descriptor starting point (oral to dermal) was not required as it is assumed that the oral and dermal absorption rates are both 50 %, in accordance with the EHCA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 example B.5.

Default parameters for extrapolation from rats to humans were used under the allometric scaling principle. Appropriate assessment factors were then applied to give an overall assessment factor of 300. These factors were used to derive a DNEL of 3.33 mg/kg bw/day.

 

Worker dermal systemic effects acute exposure DNEL:

No hazard was identified. No DNEL has been derived for acute systemic effects as no acute dermal study data is available. However, the substance is not classified as a skin irritant and is not classified as a skin sensitiser. Therefore significant acute effects are not anticipated.

 

Worker dermal local effects long-term exposure DNEL:

No hazard was identified. No DNEL has been derived for long-term dermal effects as no long-term dermal study data is available. However, the substance is not classified as a skin irritant nor as a skin sensitiser and therefore significant local effects due to repeated exposure are not anticipated.

 

Worker dermal local effects acute exposure DNEL:

The substance is not classified as a skin irritant or as a skin sensitiser. It is therefore considered unnecessary to derive acute DNEL for local effects.

 

Worker hazard for the eyes local effects DNEL:

No hazard identified. The material is not classified as an eye irritant and it is considered unnecessary to derive a DNEL.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

The substance is used solely in industry in polymer production. The substance has no general population or consumer uses and so exposure to the general population from use is not anticipated. Once the substance is used in production of polymers there should be no release, so exposure to the general population from release of the substance from final products is not anticipated.