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Registration Dossier
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EC number: 244-491-1 | CAS number: 21643-42-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 97.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route is used.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 3
- Justification:
- Considering that the entire family of long-chain acrylates did not pose any severe risk for human helath, an intraspecies difference factor of 3 for workers is considered to be sufficient
- 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 further assessment factors are required.
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:
- 138.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure.
Since dermal absoption was shown to be 0.26 % for analogous substances DNEL is derived assuming 10 % of oral absorption for dermal absorption as a worst case scenario.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 3
- Justification:
- Considering that the C12-C14 acrylates did not pose any severe risk for human helath, an intraspecies difference factor of 3 for workers is considered to be sufficient
- 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 further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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 the read-across substance 2-Propenoic acid, C12-14-alkyl esters (mixture of CAS no. 2156-97-0 and 21643-42-5) is considered low. Acute dermal toxicity was also assessed in a read-across approach. The read-across test item Laurylacrylate 1214 was not classified and labelled for acute systemic toxicity, according to Regulation (EC) No 1272/2008 (CLP). Due to the very low vapour pressure of the C12 -C14 acrylates, inhalation exposure is not considered as relevant.
Acute/short-term and long-term exposure - local effects
Skin irritation/corrosion and sensitization:
The skin irritation and sensitization potential for test item was assessed in several studies by using a read across approach with 2-Propenoic acid, C12-14-alkyl esters (mixture of CAS no. 2156-97-0 and 21643-42-5), which was demonstrated to be a skin irritant and skin sinsitizer.
Eye irritation:
The eye irritation was assessed by using read across approach. No irritation potential was observed for 2-Propenoic acid, C12-14-alkyl esters (mixture of CAS no. 2156-97-0 and 21643-42-5). Moreover, the monoalkyl or monoaryl or monoalkylaryl esters of acrylic acid are classified as irritating to eyes, respiratory tract and skin with with H315, H319 and H335 according to Regulation (EC) No 1272/2008 (CLP). Thus, a qualitative risk assessment is conducted.
Long-term exposure-systemic effects
Inhalation exposure
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in the combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test (BASF SE, 2013) is identified as the relevant dose descriptor (NOAEL = 1000 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: 1000 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 1000 mg/kg bw/day is converted in an inhalation NOAEC of 1763 mg/m3.
Taking the above mentioned assessment factors into account, the following worker DNEL is:
Worker DNEL (inhalation exposure) = 1763 mg/m3 / (1 x 6 x 1 x 3 x 1 x 1) = 1763 mg/m3 / 18 = 97.9 mg/m3
Dermal exposure
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in the combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test (BASF SE, 2013) is identified as the relevant dose descriptor (NOAEL = 1000 mg/kg bw). A low dermal absorption was shown for the structural analogous substance dodecyl methacrylate (0.26 %, Jones, O., 2002). As dodecyl acrylate has the same carbon chain length, it can be assumed that the substance penetrates the stratum corneum to a comparable extent. However, the NOAEL, taken from the oral repeated dose study, is modified assuming 10 % absorption through the skin as a worst case approach. Considering the appropriate modification and assessment factors, the worker DNEL (long-term dermal exposure) is calculated as follows:
- Modification of the dose descriptor:
Dose descriptor of relevant study: 1000 mg/kg bw/d (NOAEL)
Dermal absorption: 10 % = NOAEL x 10 = 10000 mg/kg bw/d
Taking the above mentioned assessment factors into account, the following worker DNEL is:
Worker DNEL (dermal exposure) = 10000 mg/kg bw/d / (1 x 6 x 4 x 1 x 3 x 1 x 1) = 10000 mg/kg bw/d / 72 = 138.9 mg/kg bw/d
References
- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2.1
- 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
No consumer use is intended. Therefore, no DNEL`s were derived for the general population risk assessment of Tetradecyl acrylate.
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