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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 657 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
24 726 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
8 283.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

Repeated dose toxicity data are available from 90-day studies and 2-year study in rats. The point of departure is the NOAEC from the 2 years study. Although that study is less complete, results were consistent with those from the 90-day study conducted at a higher concentration. Considering test conditions adjustment the derivation of a DNEL from the 90-day would result in a 2-fold higher value. The lowest derived value was therefore selected.

NOAEC: 5000 ppm = 24726 mg/m3

Correct for respiratory volume (from resting rat to active human): 6.7 m3/10m3 = 0.67.

Adjustment for exposure time (from 4 hour rat to 8 hour human): 4/8 = 0.5

Corrected NOAEC =24726 x 0.67 x 0.5 = 8283.2 mg/m3 (1675.0 ppm)

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
1
Justification:
study by inhalation route.
AF for other interspecies differences:
1
Justification:
Pharmacokinetics studies indicates no metabolisation of the substance, and a rapid elimination of the majority of the substance by exhaled air in both humans and animals.
AF for intraspecies differences:
5
Justification:
Default assesment factor for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
no hazard identified
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

As the substance is a gas, oral and dermal routes of exposure are considered to be irrelevant, therefore no DNELs were derived for these routes. The substance is not classified for acute toxicity, and according to REACH "Guidance on information requirements and chemical safety assessment" (R.8.4.3.1), no acute/short term exposure DNELs need to be derived.

NOAEC are available from two repeated dose toxicity studies. Considering test conditions adjustment the derivation of a DNEL from the 90-day would result in a 2-fold higher value. The lowest value was therefore selected, using the NOAEC from the 2-year study.

A NOAEC can be derived for carcinogenic effects in the 2 year study in rats and mice since no effects were observed in the study. A DNEL for CFC-12 can be derived using the NOAEC: 5000 ppm = 2.4726e+4 mg/m3 in the rat as the starting point and using the default approach proposed in the ECHA Guidance.

Calculation of DNEL for long-term exposure - carcinogenic / systemic effects in workers is derived as follows:

Description

Value

Remark

Relevant dose descriptor

Corrected NOAEC 8283.2 mg/m3 (1675.0 ppm)

NOAEC: 5000 ppm = 2.4726e+4 mg/m3

Correct for respiratory volume (from resting rat to active human): 6.7 m3/10m3 = 0.67. Correct for exposure time (from 4 hour rat to 8 hour human): 4/8 = 0.5 Corrected NOAEC =2.4726e+4 x 0.67 x 0.5 = 8283.2 mg/m3 (1675.0 ppm)

Route to route extrapolation

1

Inhalation to inhalation

Scaling factor animal to man

1

No allometric scaling per REACH R.8.4.3.1 (inhalation)

Other interspecies differences

1

Mechanistic and comparative metabolism data show a rapid elimination through exhaled air in both humans and animals following exposure, with little or no metabolism.

Intraspecies variability

5

A default assesment factor for workers, as proposed in the REACH Guidance (R 8.4.3.1)

Exposure duration

1

Chronic to chronic

Dose response

1

NOAEL available

Quality of the database

1

General assignment, long term studies available.

DNEL

Value

For workers

8283.2 / (1 x 1 x 1 x 5 x 1 x 1 x 1) =1656.6 mg/m3 = 334.97 ppm

 

The worker DNEL value derived for chronic exposure would have to be adapted in case of a different shift system (= daily exposure time). In that case the amended DNEL would result in virtually the same value under the condition that the weekly exposure time would be almost identical.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

There are no allowed uses of the substance by the general population. Following the Montral Protocol the substance is not longer used as a propellant in aerosols.

No exposure of the general population is expected.