Registration Dossier
Registration Dossier
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EC number: 231-209-7 | CAS number: 7446-81-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 mg/m³
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.5 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 224 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The worker-DNEL long-term for dermal route - systemic is derived from the NOAEL of 40 mg/kg bw/d, obtained in the chronic oral study in rats. The NOAELcorr. is calculated as follows:
- absorption (oral, rat) = 100 % (default)
- absorption (dermal, human) = 25 %--> modified dose descriptor (corrected dermal NOAEL) = 40 mg/kg bw/d * (100 %/25 %) * (7 exposure days/week; rat/5 exposure days/week; worker) = 224 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA REACH Guidance (chronic --> chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance (good/standard quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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
Based on all the available data, sodium acrylate is not subject to classification and labelling requirements under current EU regulations (Directive 67/548/EEC and Regulation (EC) No. 1272/2008).
Since sodium acrylate is of low acute toxicity with a median lethal dose value (LD50) being greater than 5000 mg/kg bw by the oral route, the DNEL derived for long-term exposure was considered sufficient to ensure the safety of human workers.
No experimental data concerning repeated dose toxicity are available for sodium acrylate. Data from the structural analogue acrylic acid which has been extensively studied, were included for the assessment and DNEL derivation.
Sodium acrylate is not irritating to skin and eyes. Therefore the local irritation effects of the structural analogue acrylic acid are not expected to occur after repeated application to sodium acrylate.
In a subchronic study with Fischer 344 rats following administration of acrylic acid in the drinking water for 90 days, the NOAEL was determined to be 83 mg/kg bw/d (IATG 1980). Following chronic exposure to acrylic acid in the drinking water, the NOAEL for male Wistar rats was 40 mg/kg bw/d (based on a reduced body weight gain), and for female rats 375 mg/kg bw/d (BASF AG 1987).
In a carcinogenicity study conducted according to OECD TG 451 and GLP regulations the only effect was a marginal reduction in water consumption noted in both sexes of the high dose group (78 mg/kg bw/d). Thus, the NOAEL for this study was set at greater than or equal to the highest dose of 78 mg/kg bw/d (BASF AG 1989). In a 2-generation-study performed according to OECD TG 416 the NOAEL with respect to general toxicity was 240 mg/kg bw/d for the F0 generation parental animals and 53 mg/kg bw/d for the F1 animals and the offspring (F1 and F2 pups). General toxicity was apparent with reduced body weights, food and water consumption in F0 parents at 460 mg/kg bw/d and in F1 parents at 240 and 460 mg/kg bw/d; the only treatment-related pathological finding was a minimal hyperkeratosis of the limiting ridge of the forestomach with a minimal edema of the submucosa of the glandular stomach in both parental generations at 460 mg/kg bw/d indicative of the irritating properties of the test substance. Since sodium acrylate does not possess any irritating properties, these effects are not anticipated for the salt.
The only effects seen in the F1 animals at the mid dose of 240 mg/kg bw/d were marginally lower mean pup weights, reduced body weight gains and reduced water consumption during pre-mating until lactation. In the F2 pups some indications were observed for delays in morphological development as secondary effect to decreased body weights (12 %) and body weight gains.
The lowest NOAEL of 40 mg/kg bw/d taken from the chronic study cited above is considered as worst case assumption for a NOAEL and thus, as appropriate starting point.
This value was modified to get the correct starting point for DNEL derivation for the dermal route (route to route extrapolation, oral to dermal). Based on the available in vitro and in vivo data of acrylic acid, dermal absorption through skin was estimated to be max. 25 % of the applied acrylic acid dose. Dermal absorption of the sodium salt is expected to be equal or lower than for the acid. Thus, the absorption difference between oral and dermal route was considered 0.25. Additionally, the differing exposure durations per week for rats (continuous treatment for 7 d per week) and workers (potential exposure on 5 d per week) were taken into account, resulting in a corrected starting point of 224 mg/kg bw/d.
The DNEL for the inhalation route can be derived from the structural analogue acrylic acid as worst-case assumption. Since sodium acrylate has a very low vapour pressure and is not expected to cause considerable dust formation, no relevant exposure by the inhalation route is to be expected. In 2006 the German MAK commission determined a scientific OEL for acrylic acid of 10 ppm (30 mg/m³) based on the irritation of the olfactory epithelium, which was confirmed as a German OEL by the regulatory authorities in 2007 and the European Scientific Committee for Occupational Exposure Limits in 2008. However, irritation of the olfactory epithelium is not expected for sodium acrylate.
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 exposure of the general population is intended or anticipated.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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