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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7 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
Modified dose descriptor starting point:
NOAEC
Value:
170.85 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC was 340 mg/m3 in an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). In the same study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). In other 90-day inhalation studies involving rats, rabbits, and dogs, no histopathological effects in brain were observed at the highest dose tested (400 ppm (2716 mg/m3)). Therefore, it is likely that 340 mg/m3 is a very conservative value. A modification (0.75) of starting point for worker exposure time as compared to animal exposure (6 hours vs. 8 hours) was applied per REACH guidance R.8.4.2. A modification (6.7m3/10m3) was applied to account for the increased respiratory volumes in active workers as compared to individuals at rest per REACH guidance R.8.4.2.
AF for dose response relationship:
1
Justification:
The dose descriptor is the most conservative NOAEL from a variety of repeated exposure studies conducted in multiple species of laboratory animals. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
AF for differences in duration of exposure:
2
Justification:
Multiple repeated inhalation studies (90-day) were conducted in multiple species (rat, rabbit and dog). Additionally, an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). There were no toxicity endpoints that increased in severity or appearance with extended exposure. Based on the extensive repeated inhalation data, an assessment factor of 2 is appropriate per REACH guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
1
Justification:
A factor of 1 is appropriate since the adjusted start point was via inhalation (mg/m3), per REACH guidance Appendix R. 8-2.
AF for other interspecies differences:
2.5
Justification:
Since there are no data to justify a reduction or increase in the interspecies default assessment factor, a default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
5
Justification:
Since there are no data to justify a reduction or increase in the intraspecies default assessment factor, a default factor of 5 is appropriate per REACH guidance R.8.4.3.1.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
AF for remaining uncertainties:
1
Justification:
A factor of 1 for route-to-route extrapolation is appropriate since the animal exposure was via inhalation per REACH guidance R.8.4.2.
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:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - workers

This substance is volatile, and is being registered as a monomer in an imported polymer. Therefore, no exposure to workers is expected, and no risk assessment is required. Our interpretation of the REACh regulation is that a DNEL is required, even if no risk assessment is required. The substance is a gas, and therefore, only a DNEL long-term exposure via the inhalation route was calculated.

This substance is classified as Acute Toxicity Category 3, STOT SE Category 3 (Respiratory irritation) and STOT RE Category 2 (Brain histopathology) according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The substance is classified as Xn:R20 Harmful by inhalation according to EU Directive 67/548/EEC.

The male and female rat 4-hour inhalation LC50= 2072 ppm (14069 mg/m3). At concentrations ≥ 2500 ppm (16975 mg/m3), the substance was judged as irritating to respiratory tissues. Multiple subchronic (90-day inhalation) studies were conducted in several species. In subchronic dog and rabbit studies, the NOEC was 100 ppm (679 mg/m3), based on respiratory irritation at exposure concentrations of 400 ppm (2716 mg/m3). In a rat 90-day subchronic study, the NOEC in male rats was 400 ppm. In female rats, decreased urine excretion volumes were observed in 100 and 400 ppm exposure groups. In an OECD 422 study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). The systemic effect NOAEC for the OECD 422 was 50 ppm (340 mg/m3). No adverse reproductive effects were observed at 500 ppm (3395 mg/m3), which was the highest concentration tested. No adverse developmental effects were observed at concentrations lower than or equal to the NOAEC for systemic toxicity in maternal animals. 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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):
50
Modified dose descriptor starting point:
NOAEC
Value:
85 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC was 340 mg/m3 in an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). In the same study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). In other 90-day inhalation studies involving rats, rabbits, and dogs, no histopathological effects in brain were observed at the highest dose tested (400 ppm (2716 mg/m3)). Therefore, it is likely that 340 mg/m3 is a very conservative value. A modification (0.25) of starting point for general population exposure time as compared to animal exposure (6 hours vs. 24 hours) was applied per REACH guidance R.8.4.2.
AF for dose response relationship:
1
Justification:
The dose descriptor is the most conservative NOAEL from a variety of repeated exposure studies conducted in multiple species of laboratory animals. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
AF for differences in duration of exposure:
2
Justification:
Multiple repeated inhalation studies (90-day) were conducted in multiple species (rat, rabbit and dog). Additionally, an OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). There were no toxicity endpoints that increased in severity or appearance with extended exposure. Based on the extensive repeated inhalation data, an assessment factor of 2 is appropriate per REACH guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
1
Justification:
A factor of 1 is appropriate since the adjusted start point was via inhalation (mg/m3), per REACH guidance Appendix R. 8-2.
AF for other interspecies differences:
2.5
Justification:
Since there are no data to justify a reduction or increase in the interspecies default assessment factor, a default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
10
Justification:
Since there are no data to justify a reduction or increase in the intraspecies default assessment factor, a default factor of 10 is appropriate per REACH guidance R.8.4.3.1.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
AF for remaining uncertainties:
1
Justification:
A factor of 1 is appropriate for route-to-route extrapolation since the animal exposure was via inhalation per REACH guidance R.8.4.2.
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:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - General Population

This substance is volatile, and is being registered as a monomer in an imported polymer. Therefore, no exposure to workers is expected, and no risk assessment is required. Our interpretation of the REACh regulation is that a DNEL is required, even if no risk assessment is required. The substance is a gas, and therefore, only a DNEL long-term exposure via the inhalation route was calculated.

This substance is classified as Acute Toxicity Category 3, STOT SE Category 3 (Respiratory irritation) and STOT RE Category 2 (Brain histopathology) according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The substance is classified as Xn:R20 Harmful by inhalation according to EU Directive 67/548/EEC.

The male and female rat 4-hour inhalation LC50= 2072 ppm (14069 mg/m3). At concentrations ≥ 2500 ppm (16975 mg/m3), the substance was judged as irritating to respiratory tissues. Multiple subchronic (90-day inhalation) studies were conducted in several species. In subchronic dog and rabbit studies, the NOEC was 100 ppm (679 mg/m3), based on respiratory irritation at exposure concentrations of 400 ppm (2716 mg/m3). In a rat 90-day subchronic study, the NOEC in male rats was 400 ppm. In female rats, decreased urine excretion volumes were observed in 100 and 400 ppm exposure groups. In an OECD 422 study, systemic toxicity (histopathological effects in brain) in male and female rats was observed at exposure concentrations ≥ 250 ppm (1698 mg/m3). The systemic effect NOAEC for the OECD 422 was 50 ppm (340 mg/m3). No adverse reproductive effects were observed at 500 ppm (3395 mg/m3), which was the highest concentration tested. No adverse developmental effects were observed at concentrations lower than or equal to the NOAEC for systemic toxicity in maternal animals.