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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.2 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:
NOAEC
Value:
1 815 mg/m³
Explanation for the modification of the dose descriptor starting point:
Not necessary; repeated dose toxicity study by inhalation is available.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
6
Justification:
Default AF for time extrapolation from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling was already considered when calculating the starting point (NOAEC).
AF for other interspecies differences:
2.5
Justification:
Default AF for other interspecies differences.
AF for intraspecies differences:
5
Justification:
The default AF for the group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
339 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not applicable in the case of local effects.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling was already considered when calculating the starting point (NOAEC)
AF for other interspecies differences:
2.5
Justification:
Default AF for other interspecies differences.
AF for intraspecies differences:
5
Justification:
The default AF for the group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
Default value
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:
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Derivation of worker DNELs for methyl vinyl ether (MVE)

General remarks

A category aproach (OECD SIDS 2006) is available for vinyl ethers: methyl vinyl ether (MVE; CAS 107-25-5), ethyl vinyl ether (EVE, CAS 109-92-2), and isobutyl vinyl ether (IBVE, CAS 109-53-5) (see chapter 13).

Data on acute oral toxicity of MVE are not available (study technically not feasable; low boiling point). In acute inhalation studies in rats the LC50 (4h) was > 20165 ppm (48 mg/L). The LD50 in acute dermal toxicity studies with cold liquid in rabbits was >5000 mg/kg bw.

Cold liquid MVE (boiling point 6°C; gaseous at room temperature) was not irritant to the skin and only slightly irritant to the eye.
Data on sensitisation are not available.

In subacute inhalation studies with MVE the NOAEC for male rats was 1500 ppm (3.6 mg/L) and the LOAEC is 3500 ppm (8.4 mg/L) due to systemic effects. In female rats the NOAEC was 3500 ppm (8.4 mg/L) due to local effects on the olfactory epithelium, clinical signs and reduced body weight at 25000 ppm (60 mg/L).

Mutagenicity and carcinogenicity:  No gene mutagenic activity of MVE was detected in the Salmonella microsome assay and HPRT assay. No clastogenic or aneugenic effects were recorded in the mouse micronucleus test. Data on carcinogenic activity are not available.

In a developmental toxicity study with MVE according to OECD TG 414  the LOAEC for maternal toxicity was 5000 ppm or 12 mg/L (lowest dose tested). At this dose level no adverse developmental effects were noted (NOEC). The NOAEC for teratogenic effects was 19500 ppm or 47 mg/L.

DNEL acute toxicity

MVE is not classified for acute toxicity. Thus, a DNEL for acute toxicity was not considered.

Worker-DNEL long-term for inhalation route-systemic

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEC: 3613 mg/m³

 

(OECD 412; inhal; rat)

Step 2) modification of the starting point

 

 

 

6 h/8 h

to 8 h exposure

 

6.7 m³/10 m³

to light work

Step 3) Assessment factors

 

 

Exposure duration

6

subacute/chronic

Interspecies

1

 No interspecies extrapolation for Inhal.

Intraspecies

5

worker

Remaining differences

2.5

 

DNEL

Value

For workers

3613 x 0.75 x 0.67 / (6 x 1 x 5 x 2.5) = 24.2 mg/m³

Worker-DNEL long-term for dermal route-systemic and local

At room temperature, MVE is an extremely flammable gas and may generate explosive atmospheres. Worker exposure is controlled by the use of closed systems, industrial hygiene controls, and personal protective equipment (OECD SIDS 2006). No exposure expected and therefore no DNEL derived.

Worker-DNEL long-term for inhalation route-local

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEC      8431 mg/m³ (OECD 412; inhal; rat)

Local effects on the olfactory epithelium

Step 2) modification of the starting point

 

 

 

6 h/8 h

to 8 h exposure

 

6.7 m³/10 m³

to light work

Step 3) Assessment factors

 

 

Exposure duration

1

Local effects

Interspecies

1

no interspecies extrapolation for Inhal.

Intraspecies

5

worker

Remaining differences

2.5

 

DNEL

Value

For workers

8431 x 0.75 x 0.67 / (1 x 1 x 5 x 2.5) = 339 mg/m³

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
903 mg/m³
Explanation for the modification of the dose descriptor starting point:
Not necessary; repeated dose toxicity study by inhalation is available.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
6
Justification:
Default AF for time extrapolation from subacute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling was already considered when calculating the starting point (NOAEC).
AF for other interspecies differences:
2.5
Justification:
Recommended AF for other interspecies differences.
AF for intraspecies differences:
10
Justification:
The default AF for the group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
84 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not applicable in the case of local effects.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling was already considered when calculating the starting point
AF for other interspecies differences:
2.5
Justification:
Recommended AF for other interspecies differences.
AF for intraspecies differences:
10
Justification:
The default AF for the group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
Default value
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

Derivation of consumer DNELs for methyl vinyl ether (MVE)

General remarks

See section "Workers".

DNEL acute toxicity

MVE is not classified for acute toxicity. Thus, a DNEL for acute toxicity was not considered.

General population-DNEL long-term for oral route-systemic

Consumer exposure to residual MVE is considered to be very low (see OECD SIDS 2006). Physico-chemical properties suggested no oral exposure. Thus, a DNEL for oral exposure was not considered.

 

General population -DNEL long-term for inhalation route-systemic

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEC: 3613 mg/m³

 

OECD 412; inhal; rat

Step 2) modification of the starting point

 

 

 

6h / 24 h

to 24h exposure)

 

1

No adoption to light work for consumers

Step 3) Assessment factors

 

 

Exposure duration

6

subacute/chronic

Interspecies

1

 No interspecies extrapolation for Inhal.

Intraspecies

10

consumer

Remaining differences

2.5

 

DNEL

Value

For consumer

3613 x 0.25 x 1 / (6 x 1 x 10 x 2.5) = 6 mg/m³

General population -DNEL long-term for dermal route-systemic + local

MVE is practically exclusively used as intermediate in the manufacture of vinyl ether polymers and co-polymers. Potentially existing residual MVE is expected to evaporate during the process of heat-treatment (OECD SIDS 2006). No dermal exposure of general population expected. Thus, no DNEL was considered.

General population-DNEL long-term for inhalation route-local

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEC      8431 mg/m³ (OECD 412; inhal; rat)

Local effects on the olfactory epithelium

Step 2) modification of the starting point

 

 

 

6h / 24 h

to 24h exposure

 

1

No adoption to light work for consumers

Step 3) Assessment factors

 

 

Exposure duration

1

local effects

Interspecies

1

 No interspecies extrapolation for Inhal.

Intraspecies

10

consumer

Remaining differences

2.5

 

DNEL

Value

For consumer

8431 x 0.25 x 1 / (1 x 1 x 10 x 2.5) = 84 mg/m³