Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.76 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
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

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Long-term inhalation exposure - systemic affects

The NOAEC for systemic toxicity was 17 ppm in a 13 -week toxicity study (Tansy et al., 1981).

Step 1) Relevant dose-descriptor          

* NOAEC rat, 7 hours/day, 5 days/week = 17 ppm

Step 2) Modification of starting point:

* Correction of exposure duration in study (7 hrs/day, 5 days/week) to default worker exposure (8 hrs/day, 5 days/ week)

* Correction for activity driven differences of respiratory volumes in workers compared to workers in rest: 6.7 m3/10 m3

Step 3) Assessment factors

* Interspecies: 2.5

For inhalation studies only a factor 2.5 is used, and no correction is made for differences in body size, because extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animal and humans breathe at a rate depending on their caloric requirements.

* Intraspecies : 5

* Exposure duration :2

* Dose response:1

* Quality of database:1

DNEL Value based on NOAEC 13-w/rats :

17 x 7/8 x 5/7 x 6.7/10 x 1/(2.5 x 5 x 2 x 1 x 1) =0.39 ppm (0.76 mg/m3)

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population