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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
17.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance and ECETOC Technical Rport No. 110
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEC
Value:
211 mg/m³
Explanation for the modification of the dose descriptor starting point:
There are no relvant experimantl data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route ist used.
AF for dose response relationship:
1
Justification:
The NOAEC is reliable. No adjustment is required.
AF for differences in duration of exposure:
2
Justification:
The NOAEC ist based on a 13-week study. AF for extrapolation from subchronic to chronic (ECHA)
AF for interspecies differences (allometric scaling):
1
Justification:
Respiratory interspecies differences are fully coverd by the factors used for route to route extrapolation.
AF for other interspecies differences:
1
Justification:
There is no evidende for species differences in the general mode of action or kinetics.
AF for intraspecies differences:
3
Justification:
Known mode of action involving ubiquious and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely (ECETOC Technical Report No. 110)
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:
2
Justification:
Data based on the read-across substance.
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:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No.110
Overall assessment factor (AF):
48
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on rpeated dermal exposure.
AF for dose response relationship:
1
Justification:
The NOAEL is reliable. No adjustment is required.
AF for differences in duration of exposure:
2
Justification:
The NOAEC ist based on a 13-week study. AF for extrapolation from subchronic to chronic (ECHA)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to humas AF 4 (ECHA)
AF for other interspecies differences:
1
Justification:
There is no evidende for species differences in the general mode of action or kinetics.
AF for intraspecies differences:
3
Justification:
Known mode of action involving ubiquious and non-specific enzyme systems (carboxylesterases, tricarboxylic acid cycle) makes a lower variability likely (ECETOC Technical Report No. 110)
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:
2
Justification:
Data based on the read-across substance.
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

General

DNEL derivation for the substance is performed under consideration of the recommendations of ECHA REACH Guidance (2010) and ECETOC (2003). In view of the data used for evaluation, the "quality of whole database factors" is considered to amount to a value of 1, and is thus not shown in the calculations presented below.

 

Acute- systemic effects

A short-term DNEL oral is not required as the acute oral toxicity of 2-propylheptyl methacrylate is considered low. It was not classified and labelled for acute systemic toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).

Acute/short-term and long-term exposure - local effects

 

Skin irritation/corrosion, eye irritation and sensitization:

The test item is not classified and labelled for skin irritation/corrosion, eye irritation or sensitization according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).

 

However, the monoalkyl or monoaryl or monoalkylaryl esters of methacrylic acid are classified as irritating to eyes, respiratory tract and skin with R36/37/38 according to Directive 67/548/EEC (DSD) and with H315, H319 and H335 according to Regulation (EC) No 1272/2008 (CLP).

A quantitative risk assessment is done.

 

Long-term exposure-systemic effects

 

Inhalation exposure

In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in a subchronic 90-day study gavage in rats with 2-ethylhexyl methacrylate (BASF SE, 2008) is identified as the relevant dose descriptor (NOAEL = 120 mg/kg bw).The oral NOAEL was converted to an inhalation NOAEC, assuming 100 % absorption via the lung and 100 % absorption via the oral route.

 

Inhalation NOAEC = oral NOAEL x 1/sRV(rat) x ABSoral(rat)/ABSinhalation(human) x sRV(human)/wRV(human)

 

With

Oral NOAEL: 120 mg/kg bw/day

sRV(rat): 0.38 m³/kg bw (8 hours) [standard respiratory volume of the rat]

ABSoral(rat)/ABSinhalation(human): 1 [ratio of oral absorption in the rat to inhalative absorption in the human]

sRV(human)/wRV(human): 6.7 m3/10 m³ [ratio of human standard respiratory volume to worker respiratory volume]

 

Accordingly, the oral NOAEL of 120 mg/kg bw/day is converted in an inhalation NOAEC of 211 mg/m³.

Taking the above mentioned assessment factors into account, the following worker DNEL is:

Worker DNEL (inhalation exposure)

= 211 mg/m3 / (1 x 2 x 1 x 1 x 3 x 1 x 2) = 211 mg/m3 / 12 =17,6 mg/m³

 

 

Dermal exposure

In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in an subchronic 90-day gavage study in rats with 2-ethylhexyl methacrylate (BASF SE, 2008) is identified as the relevant dose descriptor (NOAEL = 120 mg/kg bw). The lead effects observed were signs of non-specific, general systemic toxicity at 360 mg/kg body weight/day in both males and females. Bases on the log Pow only a low dermal uptake can be expected.

The worker DNEL (long-term dermal exposure) is calculated as follows:

 

Taking the above mentioned assessment factors into account, the following worker DNEL is:

 

Worker DNEL (dermal exposure) = 120 mg/kg bw/d / (1 x 2 x 4 x 1 x 3 x 1 x 2) = 120 mg/kg bw/d / 48 =2,5 mg/kg bw/d

 

 

References

 

- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2. ECHA-2010 -G-19 –EN.

- ECETOC (2010). Technical Report 110.Guidance on assessment factors 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 test substance was not classified and labelled regarding oral, dermal and inhalative toxicity.

Further no consumer use is intended.

Therefore no DNEL`s were derived for the general population risk assessment for 2 -propylheptyl methacrylate.