Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-592-6 | CAS number: 143-22-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 96 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 96 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 005 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 400 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.65 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.35 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: NOAEL
Workers - Hazard for the eyes
Additional information - workers
2-(2-(2-butoxyethoxy)ethoxy)ethanol
Workers
Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population
The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF(Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.
A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.
To cover the intra-species variation, the default AF(Assessment factor)of 5 for workers was applied to the concentration/dose descriptor(NOAEL or NOAEC).
The dose descriptor for dermal irritation/corrosion come fromdermalacutestudyand dermal Repeated toxicity study. In thesestudies, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.
We have taken that:
• the average weight of rats is 250g (200-300g), and the average weight of New Zealand White rabbit is2.65kg used by Moreno O.M..1976 andCorley RA, Ciesslak, Breslin WJ, Lomax,1990
• the dose is applied over an area which is approximately 10% of the total body surface, and
• the total body surface of rats is on the average 445 cm2 (363 to 527 cm2) and 1270 cm2of New Zealand White rabbit
used by Moreno O.M..1976 andCorley RA, Ciesslak, Breslin WJ, Lomax,1990
The generic modification from the NOAELtest(in mg/kg of body weight) to NOAELmodified(in mg/cm2/day) will be
NOAELtest*3.0/127= NOAELmodified
Local effects in animals after dermal exposure:
-The highest dose not causing irritation/corrosion was 2000mg/kg bw in the acute study of O.M..1976, the modified dose descriptor would be
2000mg/kg*2.65 kg/127cm2=41.73mg/cm2
-The highest dose not causing irritation/corrosion was 5025mg/kg bw in the Repeated toxicity study of Corley RA, Ciesslak, Breslin WJ, Lomax,1990, the modified dose descriptor would be5025mg/kg*0.25kg/44.5cm2=28.23mg/cm2
The substance triethylene glycol butyl ether (TEGBE or 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to TEGME. Comparable metabolism would occur. On a molecular weight scaled basis, the NOAEL would be 5025.1mg/kgbw/day.
(4000 x 206.28) / 164.2 =5025.1 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 48 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.252 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 48 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 502.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 200 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.823 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.173 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- other: NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 103.4 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Additional information - General Population
General population
Following the “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health”, the data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals. The traditional default AF(Assessment factor)suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.
Although other values have been proposed, defaults typically suggested for the general population (representing all age groups, including children and elderly) are a factor of 10.
To cover the intra-species variation, the default AF (Assessment factor)of10for General population was applied to the concentration/dose descriptor (NOAEL or NOAEC).
The dose descriptor for dermal irritation/corrosion come from dermal acute study. In this study, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.
We have taken that:
• the average weight of rats is 250g (200-300g), and the average weight of New Zealand White rabbit is2.65kg used by Moreno O.M..1976 andCorley RA, Ciesslak, Breslin WJ, Lomax,1990
• the dose is applied over an area which is approximately 10% of the total body surface, and
• the total body surface of rats is on the average 445 cm2 (363 to 527 cm2) and 1270 cm2of New Zealand White rabbit
used by Moreno O.M..1976 andCorley RA, Ciesslak, Breslin WJ, Lomax,1990
The generic modification from the NOAELtest(in mg/kg of body weight) to NOAELmodified(in mg/cm2/day) will be
NOAELtest*3.0/127= NOAELmodified
Local effects in animals after dermal exposure:
-The highest dose not causing irritation/corrosion was 2000mg/kg bw in the acute study of O.M..1976, the modified dose descriptor would be
2000mg/kg*2.65 kg/127cm2=41.73mg/cm2
-The highest dose not causing irritation/corrosion was5025mg/kg bw in the Repeated toxicity study of Corley RA, Ciesslak, Breslin WJ, Lomax,1990, the modified dose descriptor would be5025mg/kg*0.25kg/44.5cm2=28.23mg/cm2
The substance triethylene glycol butyl ether (TEGBE or 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to TEGME. Comparable metabolism would occur. On a molecular weight scaled basis, the NOAEL would be 5025.1mg/kgbw/day.
(4000 x 206.28) / 164.2 =5025.1 mg/kg bw/day
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
