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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:
88 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):
20
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 760 mg/m³
Explanation for the modification of the dose descriptor starting point:
default assessment factor for route-to-route extrapolation: 2
AF for dose response relationship:
1
Justification:
default assessment factor
AF for differences in duration of exposure:
2
Justification:
default assessment factor
Justification:
not considered, as an allometric scaling is not applied in the case of systemic effects after inhalation
Justification:
not considered, as an allometric scaling is not applied in the case of systemic effects after inhalation
AF for intraspecies differences:
5
Justification:
default assessment factor
AF for the quality of the whole database:
1
Justification:
default assessment factor
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Based on the physico-chemical properties of the substance, a significant dermal uptake is not to be expected, i.e. the dermal absorption is assumed to be 10%. See also discussion below
AF for dose response relationship:
1
Justification:
default assessment factor
AF for differences in duration of exposure:
2
Justification:
default assessment factor
AF for interspecies differences (allometric scaling):
4
Justification:
default assessment factor
AF for other interspecies differences:
2.5
Justification:
default assessment factor
AF for intraspecies differences:
5
Justification:
default assessment factor
AF for the quality of the whole database:
1
Justification:
default assessment factor
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

DNELs for acute toxicity are not considered since long-term DNEL is sufficient to ensure that these effects do not occur.

 

Skin and eye irritation/corrosion: Biofert Plusz was tested in GLP studies according to OECD guideline 404 and 405, which both gave no indications for skin and eye irritation.

 

Sensitization: Biofert Plusz was not sensitizing in a valid study performed according to OECD Guideline 429.

 

Mutagenicity: Biofert Plusz was tested negative in different in vitro mutagenicity tests.

 

Reproductive toxicity: In a study with rats dosed with Biofert Plusz, no maternal and developmental toxicity was detected in a gavage study according to OECD Guideline 414 even at the high dose level of 1000 mg/kg bw/day.

 

 

DNEL Workers

 

DNEL Long-term - inhalation, systemic effects

 

Relevant dose descriptor for the endpoint concerned: NOAEL of > 1000 mg/kg bw/day in rats in a 90-day oral toxicity study with GLP compliance according to OECD Guideline 408

 

Correction of starting point:

Differences in respiratory volumes: respiratory volume of the rat in 8 h corresponds to 0.38 m3/kg bw, additional correction for the higher standard respiratory volumes of workers compared to resting persons: correction factor = (1 ÷ 0.38) * (6.7 ÷ 10) = 1.76

Overall correction factor: 1.76

Corrected starting point: 1000 * 1.76 = 1760 mg/m3

 

Assessment factors relating to the extrapolation procedure:

Interspecies: not considered, as an allometric scaling is not applied in the case of systemic effects after inhalation

Intraspecies: 5 (default assessment factor)

Time extrapolation: 2 (default assessment factor)

Route to route extrapolation: 2 (default assessment factor)

Dose-response: 1 (default assessment factor [reliable NOAEL])

Quality of whole database: 1 (default assessment factor [completeness of available data])

Overall assessment factor: 5 * 2 * 2 * 1 * 1 = 20

 

DNEL Long-term - inhalation, systemic effects: 1760 mg/m3 ÷ 20 = 88 mg/m3

 

 

 

DNEL Long-term - dermal, systemic effects

 

Relevant dose descriptor for the endpoint concerned: NOAEL of > 1000 mg/kg bw/day in rats in a 90-day oral toxicity study with GLP compliance according to OECD Guideline 408

 

Correction of starting point:

Differences in absorption: Oral absorption is assumed to be 100%, while dermal absorption is assumed to be10[Wib1] %.

Corrected starting point: 1000 * 100 / 10 = 10000 mg/kg bw/day

 

Assessment factors relating to the extrapolation procedure:

Interspecies: 4 * 2.5 (default assessment factor for allometric scaling)

Intraspecies: 5 (default assessment factor)

Time extrapolation: 2 (default assessment factor)

Route to route extrapolation: 1 (default assessment factor)

Dose-response: 1 (default assessment factor [reliable NOAEL])

Quality of whole database: 1 (default assessment factor [completeness of available data])

Overall assessment factor: 4 * 2.5 * 5 * 2 * 1 * 1 * 1 = 100

 

DNEL Long-term - dermal, systemic effects: 10000 mg/kg bw/day ÷ 100 = 100 mg/kg bw/day


DNEL General Population

 

Only workers in the chemical or the agriculture industry might be exposed toBiofert Pluszin accidental cases. AsBiofert Pluszis not a consumer product, an exposure for the general population is not to be expected. Therefore, there is no necessity to derive DNELs for the general population.

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

Only workers in the chemical or the agriculture industry might be exposed to Biofert Plusz in accidental cases. The general population should not be exposed to Biofert Plusz since it is not a consumer product. Thus, it is not necessary to derive DNELs for the general population.