Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.64 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
DNEL value:
94 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:

TBPA has caused skin sensitization in the Buehler guinea pig test. Using the criteria in REACH Guidance R.8, Table R.8-24, TBPA would be considered "moderate". Quantiation of this endpoint for purposes of a DNEL was not attempted. Rather, the DNEL for inhalation was based on an oral 90-d study of tetrachlorophthalic anhydride in rats. The rat NOAEL in that study was 94 mg/kg bw administered by gavage, based on renal toxicity. Mice did not experience renal toxicity at any of the doses tested. This study was selected for derivation of the DNEL over the rat 21 d inhalation study due to the serious nature of the effects seen in rats in the 13 wk tetrachlorophthalic anhydride study and repeated dose studies by the dermal and oral routes of TBPA indicating similar effects. The NOAEL of 94 mg/kg bw was corrected to an inhalatory NOAEC by multiplying the NOAEL of 94 mg/kg by (1/0.38 m3/kg/d)(1/1)(6.7 m3 (8h)/10 m3 (8h) as indicated in the REACH Guidance Figure R.8-3. The corrected inhalatory NOAEC-worker = 166. Assessment factors were 2.5 for remaining species differences, 5 for worker intraspecies differences, 2 for subchronic to chronic, 1 for dose-response and quality of database. AF=25. The DNEL worker inhalation was calculated to be 0.64 mg/m3 This value is highly conservative.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
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:
7 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
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population