Registration Dossier
Registration Dossier
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EC number: 273-224-1 | CAS number: 68953-70-8 The complex combination of alkanolamines from the distillation of reaction products of ammonia and oxirane. It consists predominantly of triethanolamine, diethanolamine and higher amines from the reaction of triethanolamine and oxirane.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Dose descriptor:
- LOAEC
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:
- 6.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- 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:
- low hazard (no threshold derived)
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
According to the REACH “Guidance on information requirements and chemical safety assessment”, a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
Since Amix TE (CAS 68953 -70 -8) is composed of at least 75% of TEA (CAS 102-71-6) and the available data for Amix TE are limited, a read-across to TEA was conducted:
Acute toxicity data indicate low toxicity: in rats the oral LD50 was 6400 mg/kg bw (for TEA) and >2000 mg/kg bw (for Amix TE); in rabbits the dermal LD50 was > 2000 mg/kg bw. Inhalation exposure for 8 hours to vapour saturated with TEA failed to cause any deaths in rats (LC50 was not determined). Therefore, no acute DNELs have to be derived.
TEA is not irritating to the skin or eyes. In addition, the substance is not a skin sensitiser.
In a sub-chronic oral toxicity study, a NOAEL of 1000 mg/kg bw/day was established, the highest dose tested. In a sub-chronic dermal toxicity study, NOAELs of 125 and 250 mg/kg bw/day were established for local effects for males and females. Systemic NOAELs of 125 and 250 mg/kg bw/day were determined for males and females, respectively, based on kidney effects. Similar effects were observed in a sub-chronic dermal study in mice, performed according to the same protocol. In a sub-acute inhalation toxicity study with rats, a NOAEC for systemic effects of 0.5 mg/L was established, the highest concentration tested. 0.02 mg/L (the lowest concentration tested) was considered to be the NOAEC for local effects in females. Since slight local effects were observed in males, this concentration was determined to be the LOAEC for local effects in males.
TEA is not mutagenic and is not considered carcinogenic for humans.
Based on the available data, TEA is not considered a reproductive and developmental toxicant.
Worker DNELs
Long-term – inhalation, local/systemic effects
For TEA a MAK value of 5 mg/m3is established inbased on the available 28 day inhalation toxicity study (BASF AG, 1994). In that study a NOAEC for systemic effects of 0.5 mg/L (500 mg/m3) was established, the highest dose tested. 0.02 mg/L (20 mg/m3, the lowest concentration tested) was considered to be the NOAEC for local effects in females. Since slight local effects were observed in males, this concentration was determined to be the LOAEC for local effects in males. The justification of the MAK value of 5 mg/m3is presented in Appendix I of the CSR. The MAK value of 5 mg/m3is proposed as DNEL for workers.
Long-term – dermal, systemic effects(based on sub- and chronic dermal studies in rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 125 mg/kg bw/day |
Based on increased absolute and relative kidney weight, without any histopathological correlation. |
Step 2) Modification of starting point |
- |
- |
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Assessment factor for allometric scaling |
Intraspecies |
5 |
Default assessment factor |
Exposure duration |
1 |
No correction for exposure duration is necessary, since a 2-year study is used as starting point. |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
125 / (4 x 5 x 1 x 1 x 1) =6.3 mg/kg bw/day |
|
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- low hazard (no threshold derived)
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
No exposure of the Consumer is expected and thus no DNELs have been delineated.
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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