Registration Dossier

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.