Registration Dossier
Registration Dossier
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EC number: 205-743-6 | CAS number: 149-57-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- other: NOAEL
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:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Short term exposure worker (systemic effects)
It is not possible to derive a DNEL for acute effects based on the available data. The acute toxicity of 2-EHA is low with respect to the oral, dermal and inhalative routes of exposure. There is no acute risk to be expected from inhalation since an inhalation hazard test showed no mortality and no clinical signs after 8h exposure to saturated vapor. Furthermore, there are no uses with inhalable aerosol formation.
Long term exposure worker (systemic effects)
The DNELs for inhalation and dermal long term exposure are derived from the NOAEL (100 mg/kg bw) obtained in the oral developmental toxicity study.
Long term worker (systemic, inhalation)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/0.38 |
Route to route (8h exposure) |
|
1/1 |
Absorption oral to inhal. (complete absorption after oral uptake assumed according to toxicokinetic study) |
|
6.7 m³/10 m³ |
Correction to light work |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
1 |
No interspecies extrapolation for inhal. |
Intraspecies |
5 |
Default assessment factor for worker; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For workers |
100 mg/kg x 1 x 0.67 / (0.38 x 1 x 1 x 5 x 2.5 x 1 x 1) =14 mg/m³ |
|
Long term worker (systemic, dermal)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1 |
No correction factor for dermal absorption according to pharmacokinetic study |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
4 |
Allometric scaling from rat to human |
Intraspecies |
5 |
Default assessment factor for worker; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For workers |
100 mg/kg / (1 x 4 x 5 x 2.5 x 1 x 1) =2 mg/kg bw/d |
|
Long/short term exposure worker (local effects)
2-EHA is in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 not classified for skin, eye or respiratory irritation. The performed tests for skin and eye irritation (similar to OECD guideline 404 and 405) are indicating a slightly irritating potential. The tests are not providing dose-response data that could be used for the derivation of a DNEL. According to the REACH guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, a qualitative risk characterisation should be performed for this endpoint. In order to guarantee "adequately control of risks", it is necessary to stipulate risk management measures that prevent skin and eye exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Short term exposure consumer (systemic effects)
Same considerations as for the worker.
Long term exposure consumer (systemic effects)
The DNELs for oral, inhalation and dermal long term exposure are derived from the NOAEL (100 mg/kg bw) obtained in the oral developmental toxicity study.
Long term consumer (systemic, oral)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1 |
No correction factor for oral absorption according to pharmacokinetic study |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
4 |
Allometric scaling from rat to human |
Intraspecies |
10 |
Default assessment factor for consumer; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer |
100 mg/kg / (1 x 4 x 10 x 2.5 x 1 x 1) =1 mg/kg bw/d |
|
Long term consumer (systemic, inhalation)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1.15 |
Route to route (24h exposure) |
|
1/1 |
Absorption oral to inhal. (complete absorption after oral uptake according to toxicokinetic study) |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
1 |
No interspecies extrapolation for inhal. |
Intraspecies |
10 |
Default assessment factor for consumer; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer |
100 mg/kg x 1 / (1.15 x 1 x 1 x 10 x 2.5 x 1 x 1) =3.5 mg/m³ |
|
Long term consumer (systemic, dermal)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1 |
No correction factor for dermal absorption according to pharmacokinetic study |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
4 |
Allometric scaling from rat to human |
Intraspecies |
10 |
Default assessment factor for consumer; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer |
100 mg/kg / (1 x 4 x 10 x 2.5 x 1 x 1) =1 mg/kg bw/d |
|
Long/short term exposure consumer (local effects)
Same considerations as for the worker.
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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