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EC number: 947-343-0 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.82 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 211.6 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The NOAEC is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- The NOAEC is based on an 28 day study (OECD422). AF for extrapolation from subacute 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:
- 2.5
- Justification:
- The ECHA default value for interspecies differences is used.
- AF for intraspecies differences:
- 5
- Justification:
- The ECHA default value for the relatively homogenous 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:
- The approach used for DNEL derivation is conservative. No futher assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
As the substance is not classified for acute toxicity, no DNEL derivation is necessary.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.6 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- other:
- Explanation for the modification of the dose descriptor starting point:
Relevant dose descriptor (NOAEL): 120 mg/kg bw/day
In ECHA guidance R.8 it is stated that “substance specific data on absorption via the different routes are to be preferred.” Therefore, in the present situation experimental data from a dermal toxicokinetic study was used showing up to 10 % absorption by rat skin. This is a worst case situation as rat skin is much more permeable than human skin.
Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
Corrected NOAEL (dermal) for workers:
= 120 mg/kg bw/day/ 10 ×1.4
= 1680 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The NOAEC is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- The NOAEC is based on an 28 day study (OECD422). AF for extrapolation from subacute to chronic (ECHA).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human AF 4 (ECHA).
- AF for other interspecies differences:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous 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:
- The approach used for DNEL derivation is conservative. No futher assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
As the substance is not classified for acute toxicity, no DNEL derivation is necessary.
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Since no exposure is intended for the general population no DNEL (long-term, systemic) was derived.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
As the substance is not classified for acute toxicity, no DNEL derivation is necessary.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Since no exposure is intended for the general population no DNEL (long-term, systemic) was derived.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
As the substance in not classified for acute toxicity, no DNEL derivation is necessary.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- Oral
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The test item was no 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 of Reaction mass of nonyl methacrylate and decyl methacrylate and undecyl methacrylate.
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