Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no hazard identified
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:
21 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor:
NOAEC
Value:
21 mg/m³
AF for dose response relationship:
1
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:
no hazard identified
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)
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

Ethyl acrylate is a chemical intermediate, manufactured and processed within closed systems. The primary routes of industrial exposure to ethyl acrylate are skin contact and inhalation. In an industrial setting, ingestion is not an anticipated route of exposure.

Long-tern exposure systemic DNELs were not calculated because of the lack of long-term systemic effects. Dose-level selection for long-term studies was limited by severity of local effects on the upper respiratory tract.

DNEL derivation:

The EU Scientific Committee on Occupational Exposure Limits  (SCOEL) makes recommendations to the Commission on 'health-based' OELs. An OEL of this type may be established in those cases where a review of the total available scientific database leads to the conclusion that it is possible to identify a clear threshold dose below which exposure to the chemical in question is not expected to lead to adverse effects. The European Commission uses the scientific advice from SCOEL to make proposals for occupational exposure limits. Limits based solely on scientific considerations are considered as adaptations to technical progress, and are incorporated in proposals for Commission directives within the framework of the chemical agents directive and are indicative.

In October 2004 the EU Scientific Committee on Occupational Exposure Limits (SCOEL) recommended an 8 hour OEL (TWA) of 5 ppm (21 mg/m3) for ethyl acrylate. This recommended OEL is taken as DNEL, it is based on actual and well documented  toxicological information and evaluation of health effects, in which the approach how it is derived is scientifically justified and is therefore in accordance with ECHA Guidance on information requirments and chemical safety assessment, Chapter R.8: Characterisation of dose (concentration)-response for human health (Nov 2012).

During a long-term inhalation study in rats and mice (6h/d, 5d/w, for 27 months) reduced body weight gain was observed at exposure levels of 72 ppm (300 mg/m3) and above. Histopathological changes in olfactory portions of the nasal mucosa were present at levels of 25 ppm (100 mg/m3) and above. These microscopic exposure-related changes were concentration-dependent, primarily in terms of distribution of the lesions within the nasal cavity. In a follow-up study with 5 ppm (21 mg/m3; 6 h/d, 5 d/w, for 24 months) no treatment-related changes in the nasal mucosa were observed in rats or mice (NOAEL) (Miller et al., 1985).

When ethyl acrylate was administered to F344 rats and B6C3F1 mice chronically by gavage in doses of 100 or 200 mg/kg bw, squamous cell papillomas and carcinomas of the forestomach were observed (NTP, 1986). Results of further studies in rats indicate that the forestomach neoplasia is correlated to extensive and sustained forestomach mucosal hyperplasia and cell proliferation (Ghanayem et al., 1991, 1993, 1994) which may be caused due to severe depletion of critical cellular thiols, mainly glutathione (Gillette and Frederick, 1993; Frederick et al., 1990). There was no evidence of carcinogenicity in either rats or mice after inhalatory exposure (Miller et al., 1985) or in mice after dermal exposure (DePass et al., 1984).

There are no human data available which are adequate for proposing occupational exposure limits. In animal studies Miller et al. (1985) established a NOAEL of 5 ppm (21 mg/m3) and a LOAEL of 25 ppm3 for slight to moderate hyperplasia and metaplasia of the nasal mucosa in rats and mice after 24 or 27 months of exposure with a steep increase of effects at 75 ppm. Given a higher sensitivity of rats and mice to irritating effects in the nasal cavity (DeSesso 1992) an uncertainty factor is not considered to be necessary for proposing a occupational exposure limit. An 8-hour OEL (TWA) of 5 ppm (21 mg/m3) is recommended and a STEL (15 min) of 10 ppm (42 mg/m3) is recommended based on a pragmatic approach of multiplying the TWA OEL by a factor of 2 by SCOEL.

  • Recommendation from the Scientfic Committee on Occupational Exposure Limits for Ethyl acrylate, SCOEL/SUM/47, October 2004

In addition, a qualitative risk assessment approach was conducted for dermal local acute and long term exposure based upon skin sensitization as a hazard in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, Nov 2012). A medium hazard conclusion was based on the EC3 value of36.8 % w/v (9200 µg/cm²)

from an LLNA study (BAMM 2006).

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

Since end-use consumer products contain only trace levels of acrylic acid and esters (as a result of polymerization), consumer exposure to acrylate monomers is likely to be low (SRI, 2001).

  • SRI, 2001 . CEH Marketing Research Report, Acrylic Acid and Esters, 606 .4000A, Chemical Economics Handbook -SRI International .

Therefore, no DNELs were derived for the general population.