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Toxicological Summary

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Administrative data

Workers - Hazard via inhalation route

Systemic effects

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

DNEL for workers was not calculated for the dermal or inhalation routes since absorption of the substance thorough these routes is expected to be negligible according to the qualitative assessment of toxicokinetics. Following are the supportive argumentation:

Inhalation of Fyrolflex BDP is not expected. The substance is a viscous liquid at room temperature and has a low vapour pressure (1.2x10 -3 Pa). The Log P value is > 4 and this also does not favour absorption via passive diffusion directly across the respiratory tract epithelium.

Several skin tests were performed on Fyrolflex BDP provide a reasonable argument that Fyrolflex is not susceptible for absorption via the dermal route. The substance was determined experimentally as a non-sensitizer for skin and was not irritant in either skin or eye tests. Acute dermal toxicity data showed LD50>2000mg/kg bw. No systemic toxicity or other effects were observed. In addition, MW of 692g/mol the molecule might be too big for dermal uptake.

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

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

DNEL for general population was calculated for oral route of exposure based on experimental data (NOAEL of 1000mg/L in a 28-day repeat dose oral study). DNEL was not calculated neither for dermal nor for inhalation routes based on the following argumentation:

Inhalation of Fyrolflex BDP is not expected. The substance is a viscous liquid at room temperature and has a low vapour pressure (1.2x10 -3 Pa). The Log P value is > 4 and this also does not favour absorption via passive diffusion directly across the respiratory tract epithelium.

Several skin tests were performed on Fyrolflex BDP provide a reasonable argument that Fyrolflex is not susceptible for absorption via the dermal route. The substance was determined experimentally as a non-sensitizer for skin and was not irritant in either skin or eye tests. Acute dermal toxicity data showed LD50>2000mg/kg bw. No systemic toxicity or other effects were observed. In addition, MW of 692g/mol the molecule might be too big for dermal uptake.

However, despite of the calculated DNELoral it is unlikely that the substance will be available through the oral route according to the following argumentation: 

The molecular weight of the substance is 692g/mol, Log P=4.5 and a low solubility in water of 0.415mg/L, Fyrolflex BDP is not favorably for penetration across biological membranes and absorption into tissues (in accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7C paragraph R.7.12 ).Any potential concern with respect to possible micellular solubilisation of the Fyrolflex BDP by reaction with bile salts in the small intestine may be insignificant since there were no systemic toxic effects observed in relevant in vivo studies at extremely high dose levels (up to 1000mg/L in a 28-day repeat dose oral study).

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