Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 035 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
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:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
773 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
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:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The pattern of identified uses described for 2,2,3-trimethylbutane, includes short-term peak exposure by inhalation and the dermal route as well as long-term repeated exposure by inhalation and the dermal route. In the case of short-term exposure, it is not possible to derive a DNEL for systemic effects, since CNS toxicity (narcotic effects) and local irritation on the skin are the leading effects. Therefore, appropriate risk management measures will be identified.

 

Assessment factors were chosen on the basis of ECETOC (2003) and other, more recent, information. For route to route extrapolation, absorption differences were not taken into account.

 

References:

ECETOC (2003) Derivation of assessment factors for human health risk assessment. Technical Report No. 86, (European Centre for Ecotoxicology and Toxicology of Chemicals) Brussels.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
608 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:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
699 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
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:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
699 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The pattern of identified uses described for hydrocarbons, C7-C9, isoalkanes, includes short-term peak exposure by inhalation and the dermal route as well as long-term repeated exposure by inhalation and the dermal route. In the case of short-term exposure, it is not possible to derive a DNEL for systemic effects, since CNS toxicity (narcotic effects) and local irritation on the skin are the leading effects. Therefore, appropriate risk management measures will be identified.

 

Assessment factors were chosen on the basis of ECETOC (2003) and other, more recent, information. For route to route extrapolation, absorption differences were not taken into account.

 

References:

ECETOC (2003) Derivation of assessment factors for human health risk assessment. Technical Report No. 86, (European Centre for Ecotoxicology and Toxicology of Chemicals) Brussels