Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Long term, inhalation DNEL (workers)

The toxicological effects of diethyl ether boron trifluoride are basically driven by the toxicological properties of BF3 which is released from hydrolysis of this adduct in aqueous media. Hence, no further animal investigations are deemed necessary and for the DNEL it is proposed to overwrite the DNEL of BF3 or rather BF3 dihydrate on a molar ratio.

The subchronic study performed by Rusch et al. (1986) was considered as the study in which exposure was probably best reflecting occupational exposure conditions. In this study (Rusch et al., 1986), rats were exposed to aerosols of BF3 dihydrate for 13 weeks, the NOAEC was set at 6 mg/m3 based on the occurring kidney effects. Clinical signs of respiratory irritation were seen at all dose levels, but without abnormal histological findings. In addition, necrosis of the renal tubular epithelium could be detected.

For the derivation of the long-term DNEL, the starting point had to be modified according to Chapter R.8 of the REACH Guidance. Here, a correction for activity driven differences of respiratory volumes in workes compared to workers in rest was added to receive a starting point of 4.02 mg/m3. Additionally, an overall assessment factor of 6 was established: 2 for time extrapolation and 3 for intraspecies variability. The latter factor is lower than the dafault factor of 5 since the effects were considered to be mainly due to unspecific chemical reactivity of BF3 and hydolysis to degradation products. No enzyme polymorphism is expected to be involved. No interspecies factor was used since the exposure route of the experimental study was inhalation. Thus, applying these assessment factors, a health-based occupational exposure limit of 0.7 mg/m3 was recommended for BF3 dihydrate. Based on the molar ratio of 1:1.4, an exposure limit of 0.9 mg/m3 was calculated for diethyl ether boron trifluoride which is supposed to cover both local and systemic effects.

Description Value Remark
Step 1) Relevant dose-descriptor NOAEC: 6 mg/m3
Step 2) Modification of starting point × 6.7 m3/10 m3 According to Chapter R.8 of REACH Guidance, correction for activity driven differences of respiratory volumes in workers compared to workers in rest.
Modified dose-descriptor 6 * 0,67 =4,02 mg/m3
Step 3) Assessment factors    
Interspecies 1 No allometric scaling has to be applied in case of inhalation to inhalation route to route extrapolation. 
Intraspecies 3 Default assessment factor for workers  (decreased factor because no differences will be expected since no enzyme polimorphisms exist)
Exposure duration 2 Default assessment factor, extrapolation from sub-chronic to chronic
Dose response 1 Starting point=NOAEC
Quality of database 1  
DNEL BF3 2*H2O 4,02 / (1 × 3 × 2 × 1 × 1) =0.7 mg/m3
DNEL C4H10BF3O 0.7 * 1.4 = 0.9 mg/m3 (Mol: BF3 2*H2O=103, C4H10BF3O = 141.8 > ratio 1:1.4)

Short term inhalation DNEL (workers)

For the short-term DNEL of BF3 the German OEL of 1 mg/m3 has been employed with the following rationale: the ECHA guidance authorizes a registrant to use a national OEL instead of deriving a DNEL in case where toxicological information and evaluations of health effects used for setting the national OEL are documented and available. Therefore, it is proposed to use the German OEL (1 mg/m3 for BF3, equivalent to 1.5 mg/m3 for BF3 dihydrate) (http://www.baua.de/cae/servlet/contentblob/664358/publicationFile/47955/900-bortrifluorid-dihydrat.pdf) in place of the derivation of the DNEL. This OEL value is the lowest occupational exposure level in Europe, and is based on available and relevant toxicological data at present.

For the BF3-diethyl ether an equimolar DNEL of 2.1 mg/m³ is proposed.

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

There are only industrial uses for BF3 and its dietherate. The rejects of the substance in the environment (water, air) is extremely low. General population is not exposed via inhalation, dermal or oral route. Therefore no DNEL is calculated for the general population.