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EC number: 223-032-9 | CAS number: 3699-54-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 44.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 125 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Kinetics (absorption figures for oral, dermal and inhalation route of exposure)
No data on absorption are available. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information on the starting route, to include a default factor of 2 in the case of oral-to-inhalation extrapolation. This approach will be taken forward to DNEL derivation. For dermal absorption, based on the physico-chemical properties of the substance (log Kow < -1 and water solubility > 10000 mg/L) low dermal uptake is expected. Therefore the ratio of 0.1 for derfmal to oral absorption is provisionally suggested for DNEL derivation.
Acute toxicity
1-(2-hydroxyethyl)imidazolidin-2-one does not have to be classified for acute toxicity and therefore derivation of a DNELacuteis not necessary.
Repeated dose toxicity
The study considered for DNEL derivation of 1-(2-hydroxyethyl)imidazolidin-2-one is the combined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) in rats. 1-(2-hydroxyethyl) imidazolidin-2-one was administered daily to rats by gavage at doses of 0, 100, 300 or 1000 mg/kg bw/day. There were no treatment-related deaths, clinical signs of systemic toxicity, treatment-related effects on body weight or feed consumption in females during premating, gestation and lactation, or in males throughout the study at any dose level. No treatment-related effects were seen in the Functional Observational Battery (FOB) parameters. There were no treatment-related changes in any hematology or clinical chemistry parameters in either sex at any dose level. No treatment-related changes in organ weights were noted in either sex at any dose level. No treatment-related gross or microscopic pathological findings were observed in either sex at any dose level. In the offspring, there were no treatment-related effects body weight at any dose. There were no external abnormalities noted at any dose level. There were no treatment-related deaths or clinical signs of systemic toxicity in pups during lactation at any dose level.Therefore, the NOAEL of 1000 mg/kg derived from the combined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) in rats was used.
Mutagenicity
1-(2-hydroxyethyl)imidazolidin-2-one was not mutagenic in several Ames tests and not mutagenic in the in vivo chromosome aberration test.
No HPRT study is available for 1-(2-hydroxyethyl) imidazolidin-2-one.2-imidazolidone is a structural analogue of 1-(2-hydroxyethyl) imidazolidin-2-one. Under the conditions of a HPRT test with 2-imidazolidone, the test substanceis considered to be non-mutagenic.
Reproduction toxicity
No developmental toxicity was observed in acombined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) in rats with 1-(2-hydroxyethyl)imidazolidin-2-one (tested at 0, 100, 300 or 1000 mg/kg bw/day). Thus, the NOAEL for developmental and reproductive toxicity was considered 1000 mg/kg bw/day. No DNEL has to be derived for developmental and reproductive toxicity.
Worker DNELs
Long-term – dermal, systemic effects (based on combined oral toxicity, reproduction/developmental toxicity screening study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects were observed up to the highest dose tested. |
Step 2) Modification of starting point |
0.1 |
Based on low log Kow and very high water solubility, dermal absorption is expected to be low. This is supported by the estimated Kp valueof 2.94E-05 cm/h using the Danish (Q)SAR Database (EPI Suite, DERMWIN V 2.09) indicative for a very low dermal penetration potential according to DK-EPA heuristics (User Manual for the Internet Version of the Danish (Q)SAR Database, Database Version 1, May 2005). Therefore, a ratio of 0.1 for dermal to oral absorption is therefore provisionally suggested for DNEL derivation. |
Modified dose-descriptor |
1000 / 0.1 = 10000 mg/kg bw/day |
|
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Assessment factor for allometric scaling. As no adverse effects have been observed in toxicological studies an additional assessment factor for "remaining differences" has not been applied. |
Intraspecies |
5 |
Default assessment factor |
Exposure duration |
4 |
As exposure duration was 8 weeks, factor 4 is proposed for the extrapolation to chronic exposure |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
10000 / (4 x 5 x 4 x 1 x 1) = 125 mg/kg bw/day |
|
Long-term - dermal, local effects
No data are available based on which a DNEL for local effects can be derived. As the substance is not irritating to skin, no local effects are also expected by repeated dermal exposure.
Long-term –inhalation, systemic effects (based on combined oral toxicity, reproduction/developmental toxicity screening study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects were observed up to the highest dose tested. |
Step 2) Modification of starting point |
2
0.38 m3/kg bw
6.7 m3/10 m3 |
Ratio of inhalation to oral absorption (default value, as proposed in the REACH guidance (R.8.4.2)
Standard respiratory volume of a rat, corrected for 8 h exposure, as proposed in the REACH Guidance (R.8.4.2)
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3). |
Modified dose-descriptor |
1000 / 2 / 0.38 x (6.7/10) = 881.6 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
1 |
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation. |
Intraspecies |
5 |
Default assessment factor |
Exposure duration |
4 |
As exposure duration was 8 weeks, factor 4 is proposed for the extrapolation to chronic exposure |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
881.58 / (1 x 5 x 4 x 1 x 1) = 44.1 mg/m3 |
|
Long-term - inhalation, local effects
No data are available based on which a DNEL for local effects can be derived. There are also no data to suggest that the substance may cause local effects by inhalation exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 62.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 160
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 160
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Long-term – dermal, systemic effects (based on combined oral toxicity, reproduction/developmental toxicity screening study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects were observed up to the highest dose tested |
Step 2) Modification of starting point |
0.1 |
Based on low log Kow and very high water solubility, dermal absorption is expected to be low.This is supported by the estimated Kp valueof 2.94E-05 cm/h using the Danish (Q)SAR Database (EPI Suite, DERMWIN V 2.09) indicative for a very low dermal penetration potential according to DK-EPA heuristics (User Manual for the Internet Version of the Danish (Q)SAR Database, Database Version 1, May 2005).Therefore, a ratio of 0.1 for dermal to oral absorption is therefore provisionally suggested for DNEL derivation. |
Modified dose-descriptor |
1000 / 0.1 = 10000 mg/kg bw/day |
|
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Assessment factor for allometric scaling. As no adverse effects have been observed in toxicological studies an additional assessment factor for "remaining differences" has not been applied. |
Intraspecies |
10 |
Default assessment factor |
Exposure duration |
4 |
As exposure duration was 8 weeks, factor 4 is proposed for the extrapolation to chronic exposure |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
10000 / (4 x 10 x 4 x 1 x 1) = 62.5 mg/kg bw/day |
|
Long-term - dermal, local effects
No data are available based on which a DNEL for local effects can be derived. As the substance is not irritating to skin, no local effects are also expected by repeated dermal exposure.
Long-term – inhalation, systemic effects (based on combined oral toxicity, reproduction/developmental toxicity screening study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects were observed up to the highest dose tested. |
Step 2) Modification of starting point |
2
1.15 m3/kg bw
|
Proportion inhalation absorption (default value, as proposed in the REACH guidance (R.8.4.2)
Standard respiratory volume of a rat, corrected for 24 h exposure, as proposed in the REACH Guidance (R.8.4.2)
|
Modified dose-descriptor |
1000 / 2 x (1/1.15)= 434.8 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
1 |
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation. |
Intraspecies |
10 |
Default assessment factor |
Exposure duration |
4 |
As exposure duration was 8 weeks, factor 4 is proposed for the extrapolation to chronic exposure |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
434.8 / (1 x 10 x 4 x 1 x 1) = 10.9 mg/m3 |
|
Long-term - inhalation, local effects
No data are available based on which a DNEL for local effects can be derived. There are also no data to suggest that the substance may cause local effects by inhalation exposure.
Long-term – oral, systemic effects (based on combined oral toxicity, reproduction/developmental toxicity screening study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects were observed up to the highest dose tested. |
Step 2) Modification of starting point |
- |
- |
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Assessment factor for allometric scaling. As no adverse effects have been observed in toxicological studies an additional assessment factor for "remaining differences" has not been applied. |
Intraspecies |
10 |
Default assessment factor |
Exposure duration |
4 |
As exposure duration was 8 weeks, factor 4 is proposed for theextrapolation to chronic exposure |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
1000 / (4 x 10 x 4 x 1 x 1) = 6.3 mg/kg bw/day |
|
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