Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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