4-hydroxybutyl acrylate

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.98 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):

25

Dose descriptor starting point:

NOAEL

Value:

40 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

49.37 mg/m³

Explanation for the modification of the dose descriptor starting point:

Relevant dose descriptor (NOAEL): 40 mg/kg bw/day

Oral absorption of the rat / inhalation absorption of humans (ABS oral-rat / ABS inh-human): 50/100

Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw/day

Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³

Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³

Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker

Corrected NOAEC (inhalation) for workers:

= 40 mg/kg bw/day× 0.5 × (1 / 0.38 m³/kg bw/day) × (6.7 m³/10 m³) × 1.4

= 49.37 mg/m³

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:

2

Justification:

Extrapolation from sub-chronic to chronic exposure.

AF for interspecies differences (allometric scaling):

1

Justification:

No allometric scalling is applied for inhalation as the inhalative data is standardized with reference to the respiratory rates. Respiratory rates depend directly on caloric demand, therefore inhalative study results are already extrapolated to humans on the basis of metabolic rate scaling (=allometric scaling).

AF for other interspecies differences:

2.5

Justification:

The recommended AF for other interspecies differences is applied.

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 OECD TG 408 toxicity study was conducted according to regulatory standards and was adequately reported. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.

AF for remaining uncertainties:

1

Justification:

DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

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:

3 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

other: TLV-TWA recommended by AGGIH

Overall assessment factor (AF):

10

Dose descriptor:

LOAEC

Value:

24 mg/m³

AF for dose response relationship:

3

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, consideration should be given to the uncertainties in extrapolation of the LOAEC to the NAEC. It is suggested to use an assessment factor between 3 (as minimum/majority of cases) and 10 (as maximum/exceptional cases). Taking into account the dose spacing in the experiment (5-fold), as well as the (tendency to a) concentration dependent increase in incidence and severity of the lesion from mid to high concentration in both sexes, it is suggested to use an assessment factor of 3.

AF for differences in duration of exposure:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, a factor allowing for differences in the experimental exposure duration and the duration of exposure for the worker and scenario under consideration needs to be considered taking into account that a) in general the experimental NOAEL will decrease with increasing exposure times and b) other and more serious adverse effects may appear with increasing exposure times. Consequently, to end up with the most conservative DNEL for repeated dose toxicity, chronic exposure is the ‘worst case’. So, as only a sub-chronic toxicity study is available, default assessment factor of 2 is to be applied, as a standard procedure. However, as the DNEL is derived based on on local effects exposure duration is not expected to influence the effect. An assessment factor of 1 is therefore considered to be sufficient.

AF for interspecies differences (allometric scaling):

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, an assessment factor for allometric scaling is not needed because the effects are not dependent on metabolic rate or systemic absorption (i.e. it concerns a local effect).

AF for other interspecies differences:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, an assessment factor for allometric scaling is not needed because the effects are not dependent on metabolic rate or systemic absorption (i.e. it concerns a local effect).

AF for intraspecies differences:

3

Justification:

In accordance with ECETOC Derivation of Assessment Factors for Human Health Risk Assessment – Technical Report No. 86 and ECETOC Guidance on Assessment Factors to Derive a DNEL – Technical Report No. 110, a default assessment factor for the general population is based on the distributions of human data for various toxicokinetic and toxicodynamic parameters. The upper extreme of the variability in these data was estimated by calculating the 95th percentile of the distribution, which is considered sufficiently conservative to account for intraspecies variability in the general population (the data analysed included both sexes, a variety of disease states and ages). This results in recommended default assessment factor of 5 for the general population. As the worker population is more homogeneous (i.e. younger, healthier, protected from exposures), a default assessment factor of 3 is recommended. This proposal of ECETOC is based on an evaluation of the available scientific literature while the ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health refers to standard default procedures. Until the scientific basis for using an alternative approach has been established, it is proposed to follow the ECETOC guideline.

AF for the quality of the whole database:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterization of dose [concentration]-response for human health, the evaluation of the total toxicological database should include an assessment whether the available information as a whole meets the tonnage driven data requirements necessary to fulfil the REACH requirements, or whether there are data gaps (completeness of the database). Furthermore, the hazard data should be assessed for the reliability and consistency across different studies and endpoints and taking into account the quality of the testing method, size and power of the study design, biological plausibility, dose-response relationships and statistical association (adequacy of the database). When taking into account the standard information requirements and the completeness and consistency of the database the default assessment factor of 1, to be applied for good/standard quality of the database, is recommended.

AF for remaining uncertainties:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, a factor allowing for remaining uncertainties should be used where necessary. As the approach used for DNEL derivation is conservative, no further assessment factors are required.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

other: TLV-TWA recommended by AGGIH

Overall assessment factor (AF):

10

Dose descriptor starting point:

LOAEC

Value:

24 mg/m³

AF for dose response relationship:

3

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, consideration should be given to the uncertainties in extrapolation of the LOAEC to the NAEC. It is suggested to use an assessment factor between 3 (as minimum/majority of cases) and 10 (as maximum/exceptional cases). Taking into account the dose spacing in the experiment (5-fold), as well as the (tendency to a) concentration dependent increase in incidence and severity of the lesion from mid to high concentration in both sexes, it is suggested to use an assessment factor of 3.

AF for interspecies differences (allometric scaling):

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, an assessment factor for allometric scaling is not needed because the effects are not dependent on metabolic rate or systemic absorption (i.e. it concerns a local effect).

AF for other interspecies differences:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, an assessment factor for allometric scaling is not needed because the effects are not dependent on metabolic rate or systemic absorption (i.e. it concerns a local effect).

AF for intraspecies differences:

3

Justification:

In accordance with ECETOC Derivation of Assessment Factors for Human Health Risk Assessment – Technical Report No. 86 and ECETOC Guidance on Assessment Factors to Derive a DNEL – Technical Report No. 110, a default assessment factor for the general population is based on the distributions of human data for various toxicokinetic and toxicodynamic parameters. The upper extreme of the variability in these data was estimated by calculating the 95th percentile of the distribution, which is considered sufficiently conservative to account for intraspecies variability in the general population (the data analysed included both sexes, a variety of disease states and ages). This results in recommended default assessment factor of 5 for the general population. As the worker population is more homogeneous (i.e. younger, healthier, protected from exposures), a default assessment factor of 3 is recommended. This proposal of ECETOC is based on an evaluation of the available scientific literature while the ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health refers to standard default procedures. Until the scientific basis for using an alternative approach has been established, it is proposed to follow the ECETOC guideline.

AF for the quality of the whole database:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterization of dose [concentration]-response for human health, the evaluation of the total toxicological database should include an assessment whether the available information as a whole meets the tonnage driven data requirements necessary to fulfil the REACH requirements, or whether there are data gaps (completeness of the database). Furthermore, the hazard data should be assessed for the reliability and consistency across different studies and endpoints and taking into account the quality of the testing method, size and power of the study design, biological plausibility, dose-response relationships and statistical association (adequacy of the database). When taking into account the standard information requirements and the completeness and consistency of the database the default assessment factor of 1, to be applied for good/standard quality of the database, is recommended.

AF for remaining uncertainties:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, a factor allowing for remaining uncertainties should be used where necessary. As the approach used for DNEL derivation is conservative, no further assessment factors are required

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

8.2 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):

24

Dose descriptor starting point:

NOAEL

Value:

196 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

196 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated dermal exposure. The recommended approach using oral data assuming a similar absorption via the dermal route (end route) as compared to the oral route (starting route) is used. For details, please refer to the discussion.

AF for dose response relationship:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, for the dose-response relationship, consideration should be given to the uncertainties in the dose descriptor (NOAEL, benchmark dose…) as the surrogate for the true no-adverse-effect-level (NAEL). In this case the starting point for the DNEL calculation is a NOAEL, derived from a study which is of good quality and without uncertainties. Therefore the default assessment factor, as a standard procedure, is 1.

AF for differences in duration of exposure:

2

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, a factor allowing for differences in the experimental exposure duration and the duration of exposure for the worker and scenario under consideration needs to be considered taking into account that a) in general the experimental NOAEL will decrease with increasing exposure times and b) other and more serious adverse effects may appear with increasing exposure times. Consequently, to end up with the most conservative DNEL for repeated dose toxicity, chronic exposure is the ‘worst case’. So, as a sub-chronic toxicity study is extrapolated to chronic, an assessment factor of 2 is to be applied.

AF for interspecies differences (allometric scaling):

4

Justification:

In accordance with ECETOC Derivation of Assessment Factors for Human Health Risk Assessment – Technical Report No. 86 and ECETOC Guidance on Assessment Factors to Derive a DNEL – Technical Report No. 110, potential differences in biological sensitivity between species are largely accounted for in the default assessment factor proposed for intraspecies variability. An allometric scaling factor of 4, for the differences between rats and humans, is used.

AF for other interspecies differences:

1

Justification:

In accordance with ECETOC Derivation of Assessment Factors for Human Health Risk Assessment – Technical Report No. 86 and ECETOC Guidance on Assessment Factors to Derive a DNEL – Technical Report No. 110, potential differences in biological sensitivity between species are largely accounted for in the default assessment factor proposed for intraspecies variability.

AF for intraspecies differences:

3

Justification:

In accordance with ECETOC Derivation of Assessment Factors for Human Health Risk Assessment – Technical Report No. 86 and ECETOC Guidance on Assessment Factors to Derive a DNEL – Technical Report No. 110, a default assessment factor for the general population is based on the distributions of human data for various toxicokinetic and toxicodynamic parameters. The upper extreme of the variability in these data was estimated by calculating the 95th percentile of the distribution, which is considered sufficiently conservative to account for intraspecies variability in the general population (the data analysed included both sexes, a variety of disease states and ages). This results in recommended default assessment factor of 5 for the general population. As the worker population is more homogeneous (i.e. younger, healthier, protected from exposures), a default assessment factor of 3 is recommended. This proposal of ECETOC is based on an evaluation of the available scientific literature while the ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health refers to standard default procedures. Until the scientific basis for using an alternative approach has been established, it is proposed to follow the ECETOC guideline.

AF for the quality of the whole database:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterization of dose [concentration]-response for human health, the evaluation of the total toxicological database should include an assessment whether the available information as a whole meets the tonnage driven data requirements necessary to fulfil the REACH requirements, or whether there are data gaps (completeness of the database). Furthermore, the hazard data should be assessed for the reliability and consistency across different studies and endpoints and taking into account the quality of the testing method, size and power of the study design, biological plausibility, dose-response relationships and statistical association (adequacy of the database). When taking into account the standard information requirements and the completeness and consistency of the database the default assessment factor of 1, to be applied for good/standard quality of the database, is recommended.

AF for remaining uncertainties:

1

Justification:

In accordance with ECHA Guidance on information requirements and chemical safety assessment – Chapter 8: Characterisation of dose [concentration]-response for human health, a factor allowing for remaining uncertainties should be used where necessary. As 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:

medium hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

medium hazard (no threshold derived)

Additional information - workers

Most acrylates are chemical intermediates, manufactured and processed within closed systems. The primary route of industrial exposure to 4-hydroxybutyl acrylate is skin contact and inhalation. In an industrial setting, ingestion is not an anticipated route of exposure.

DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2010). In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.

Since neither sub-chronic nor chronic repeated dose studies were available for 4-hyroxybutyl acrylate, DNELs were derived by read across to the structural analogues 2-hydroxyethyl acrylate and hydroxypropyl acrylate as they have similar toxicological, physico-chemical and ecotoxicological properties compared to the test substance.

Acute, systemic DNEL

Short term DNELs are not required as the acute toxicity of 4-hydroxybutyl acrylate is low. The test substance is classified and labelled for acute oral toxicity as R22 according to Directive 67/548/EEC (DSD) and as category 4 (H302) according to Regulation (EC) No 1272/2008 (CLP). No classification and labelling is required for acute dermal and inhalation toxicity.

Acute/ longterm, local

Inhalation: No long-term studies with repeated dose regimen are available for 4-hydroxybutyl acrylate (HBA). However, data from the structural analogues 2-hydroxyethyl acrylate (HEA, CAS No. 818-61-1) and hydroxypropyl acrylate (HPA, CAS No. 25584-83-2) are considered suitable for the assessment and as starting point for DNEL derivation. Based on the structural similarity of the three hydroxy acrylates HEA, HPA and HBA and due to their corrosivity, a toxicological behaviour after repeated inhalation can be expected for 4-hydroxybutyl acrylate comparable to the other two substances. However, vapour pressure for HBA was measured to be considerably lower than for HEA respectively to some extent lower than for HPA. Therefore, read across to HEA and HPA for the inhalation route and DNEL derivation based on these data might represent a worst case assumption for HBA.

Long-term exposure systemic DNELs were not calculated due to the lack of long-term systemic effects. Dose-level selection for long-term studies was limited by severity of local effects of ocular, nasal, and respiratory tract irritation. The most critical effect of 4-hydroxybutyl acrylate (HBA) is its corrosive property, it causes burns to skin and eyes in animals and potentially irritation in the respiratory tract.

For hydroxypropyl acrylate (HPA) the American Conference of Governmental Industrial Hygienists (ACGIH) has recommended a Threshold Limited Value-time weighted average TLV-TWA of 0.5 ppm (2.8 mg/m3) in 1999. This value was based on the following data:

28-days sub-acute studies by the inhalation route were conducted in male Sprague-Dawley rats, male Swiss-Webster mice, male Beagle dogs, and male New Zealand White rabbits (Dow Chemical Company 1983). The animals were exposed for 6 hours per day, 5 days per week for a total of 20 exposures for dogs and rabbits and 21 exposures for rats and mice in 30-31 days at vapour concentrations of 5 ppm (0.027 mg/L) and 10 ppm (0.053 mg/L), respectively. Rats, dogs and rabbits developed signs of nasal, respiratory, and ocular irritation at both exposure concentrations. Thus, LOAEC values that were determined for these three species, were 5 ppm. Mice showed signs of eye irritation only at the high-dose of 10 ppm; therefore, the corresponding NOAEC was set at 5 ppm. No sub-chronic or chronic repeated dose studies by the inhalation route are available for HPA.

For the structural analogue 2-hydroxyethyl acrylate (HEA) there is also a 28-days sub-acute study available conducted in male rats (Dow Chemical Company 1970). The animals were exposed for 7 hours/ day, 5 days/ week, for a total of 20 exposures at vapour concentrations of 5, 10, and 25 ppm (corresponding to approx. 24, 48, and 120 mg/m3).HEA produced ulcerative keratitis at dose levels of 25 ppm, 10 ppm, and 5 ppm; focal ulcerative rhinitis at 25 ppm and 10 ppm; chronic-active laryngitis at the 25 ppm and 10 ppm levels; and chronic-active tracheitis at the 25 ppm, 10 ppm, and 5 ppm levels. Thus, no NOAEC was derived in this study; the LOAEC based on severe local irritation effects (ulcerative keratitis and chronic-active tracheitis) was 5 ppm.

Unfortunately, evaluation of the respiratory system was most difficult in this study due to the high incidence of chronic murine pneumonia in the control and HEA exposed rats. Therefore, it was impossible to evaluate subtle pulmonary lesions with regard to HEA exposure. In addition, a chronic inhalation study was conducted in male and female Sprague-Dawley rats (99 or 100 animals per sex per dose group) that were exposed to HEA 6 hours per day, 5 days/week for 18 months at concentrations of 0.5 ppm (2.4 mg/m3) and 5 ppm (24 mg/m3), respectively (Dow Chemical Company 1979). This study included a 12-month interim kill for pathological and cytogenetic examination. Overall treatment was not associated with adverse effects except that the rats in the 5 ppm treatment group developed a marginal increase in Mycoplasma-induced pneumonia which was interpreted as being treatment-related. No treatment-related effects were seen in the 0.5 ppm group. The quality of both of these studies suffered from some limitations, in particular due to the occurrence of chronic murine pneumonia and Mycoplasma-induced pneumonia respectively, in both control and treated animals.

Taking the data from both structurally related substances into account, the LOAEC derived from the sub-acute studies in both substances and from four animal species (5 ppm) appears to be an appropriate point of departure for DNEL derivation. For extrapolation of the LOAEC to the NOAEC, an assessment factor of 3 is acceptable (ECHA, R.8, December 2010). Since the point of departure is based on local effects on the respiratory tract, no additional assessment factors for duration extrapolation and interspecies differences are needed. For intraspecies differences an assessment factor of 3 is considered to be sufficient (ECETOC TR 110, 2010). Thus, the overall assessment factor added up to 9. Applying conservatively an AF of 10 to the point of departure, a DNEL of 0.5 ppm (3.0 mg/m3) is derived. This assessment is strongly supported by the TLV-TWA of 0.5 ppm which was recommended by ACGIH for HPA (1999).

•AGGIH (2001). 2-Hydroxypropyl Acrylate. TLV-TWA.

•ECETOC (2010). Guidance on Assessment Factors to Derive a DNEL. Technical Report No. 110, October 2010.

•ECHA (2010). Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.8: Characterisation of Dose [Concentration]-Response for Human Health.

Skin sensitisation: 4-hydroxybutyl acrylate is considered a skin sensitiser based on data recovered in several in vivo and in vitro studies with the test item itself and with structural analogues like 2-hydroxyethyl acrylate and hydroxypropyl acrylate. Thus a qualitative risk assessment is conducted.

Skin and eye irritation: 4-hydroxybutyl acrylate is considered as a moderate skin and eye irritant based on data from several studies. No threshold could be derived therefore a qualitative risk assessment is conducted.

Long term, systemic DNEL

Occupational exposure to 4-hydroxybutyl acrylate occurs mainly by dermal route, and may also occur by inhalation exposure. As no long term systemic effects were discovered for inhalation exposure no DNEL will be calculated. To cover eventual systemic effects, the local long term and local short term DNEL are used. Therefore only one long-term DNEL is calculated for workers. In view of the data used for evaluation, the "quality of whole database factor" and "dose-response factor" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.

Dermal exposure

Step 1: Selection of the relevant dose descriptor (starting point):

The study equivalent to OECD TG 408 with 2-hydroxyethyl acrylate (1967) is selected for DNEL derivation as it is the relevant repeated dose study. The oral NOAEL, based on the highest dose tested, is 196 mg/kg bw/d air for the read across substance.

Step 2: Modification into a correct starting point:

Correction for dermal absorption rates of 2-hydroxyethyl acrylate (based on Guidance on information requirements and chemical safety assessment, Chapter R 7.12): Dermal absorption is supposed to be high for several reasons: 1. High water solubility (1000 g/L, 2. Low log Kow of 0.44. Taken together with the molecular weight of 144 g/mol dermal uptake is anticipated to be high. In addition, the results of the irritation studies support a high absorption via dermal route. Therefore, dermal absorption can be reasonably estimated to be the same as oral absorption. In conclusion, dermal NOAEL = oral NOAEL = 196 mg/kg bw/d.

Step 3: Use of assessment factors: 24

Interspecies AF, allometric scaling (rat to human): 4

Intraspecies AF (worker): 3

Exposure duration AF: 2 (subchronic to chronic)

In conclusion, long term systemic dermal DNEL, workers = 8.2 mg/kg bw/day

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

Acute/short-term local/systemic effects

End-use consumer products contain only trace amounts of acrylic acid and esters (as a result of polymerization). Therefore consumer exposure to acrylate monomers is likely to be low (SRI, 2001). General population is not exposed to 4-hydroxybutyl acrylate by inhalation or dermal exposure. The release of the substance in the environment (water, air) is extremely low. Therefore no inhalation and no dermal DNEL were derived for general population. An oral long-term DNEL was not calculated for general population as secondary poisoning is not applicable. The substance is readily biodegradable. Therefore the substance does not accumulate in food chains and an oral long-term DNEL does not need to be derived.

References (not included as endpoint study record)

- ECHA (2011). Guidance on information requirements and chemical safety assessment. Part B: Hazard assessment. Version 2. ECHA-11-G-09-EN.

- 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.

- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. May 2008