Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15.2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: adoption of the work place limit value of structurally related amines
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15.2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: adoption of the work place limit value of structurally related amines
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15.2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: adoption of the work place limit value of other structurally related amines

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Alkylamines are caustic, and local effects prevail over systemic effects, i.e. it is not possible to reach dose levels which produce systemic toxicity. Therefore, it is proposed to compare existing MAK-values for alkylamines. These take experimental results and human experience at the workplace into consideration. Irritation in humans is expected to occur at 10 ppm and above. This is largely based on the pKa value, and therefore there is only little difference between primary, secondary, and tertiary saturated linear or branched alkylamines (cf. justification for monobutylamines in section 13). As a result MAK values range from 2 to 5 ppm. For TnBA a conservative MAK value of 2 ppm is proposed. This value is considered conservative because it was established for primary butylamines on the basis of mucous membrane irritation (i.e. RD50 values for respeiratory depression i mice). In contrats to monobutylamine, TnBA was not sufficiently irritating to reach a 50% respiratory depression. By definition MAK values are derived to provide a long-term worker protection, and therefore they can also be used as a worker long-term inhalation DNEL value.

It should be noted that tributylamine caused pulmonary irritation (tRD50 = 96 ppm) in mice. Sensory irritation was minor, unlike findings with other alkylamines. The authors proposed a TLV in the range 1 to 2.2 ppm (Nielsen and Yamagiwa, 1989). The conversion is 1 ppm = 7.70 mg/m³ (20°C).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

No data derived, considered to be not relevant, as the general public is no target population.