Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.13 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
9
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
45
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

DMELs were not calculated. The weight-of-the-evidence from the genotoxicity and carcinogenicity studies support that DETDA is not genotoxic and not a carcinogen at doses that do not cause excessive toxicity.     

REFERENCES

ECHA (2008) Guidance on information requirements and chemical safety assessment, Chapter R.8: Charactersation of dose [concentration]-response for human health, European CHemicals Agency (ECHA), GUIDEANCE FOR THE IMPLEMENTATION OF REACH, pp. 1 -150.

ECETOC (2003) Derivation of assessment factors for human health risk assessment, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), TECHNICAL REPORT NO. 86, pp. 1-86.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
BMDL10
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

DMELs were not calculated. The weight-of-the-evidence from the genotoxicity database and three carcinogenicity studies support that DETDA is not genotoxic and not a carcinogen at doses that do not cause excessive toxicity.    

REFERENCES

ECHA (2008) Guidance on information requirements and chemical safety assessment, Chapter R.8: Charactersation of dose [concentration]-response for human health, European CHemicals Agency (ECHA), GUIDEANCE FOR THE IMPLEMENTATION OF REACH, pp. 1 -150.

ECETOC (2003) Derivation of assessment factors for human health risk assessment, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), TECHNICAL REPORT NO. 86, pp. 1-86.