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EC number: 923-725-2
CAS number: -
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.
Biofert Plusz was not sensitizing in a valid study performed according
to OECD Guideline 429.
Biofert Plusz was tested negative in different in vitro mutagenicity
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.
Long-term - inhalation, systemic effects
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
of starting point:
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
correction factor: 1.76
starting point: 1000 * 1.76 = 1760 mg/m3
factors relating to the extrapolation procedure:
not considered, as an allometric scaling is not applied in the case of
systemic effects after inhalation
5 (default assessment factor)
extrapolation: 2 (default assessment factor)
route extrapolation: 2 (default assessment factor)
1 (default assessment factor [reliable NOAEL])
whole database: 1 (default assessment factor [completeness of available
assessment factor: 5 * 2 * 2 * 1 * 1 = 20
Long-term - inhalation, systemic effects: 1760 mg/m3 ÷ 20 = 88 mg/m3
Long-term - dermal, systemic effects
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
4 * 2.5 (default assessment factor for allometric scaling)
route extrapolation: 1 (default assessment factor)
assessment factor: 4 * 2.5 * 5 * 2 * 1 * 1 * 1 = 100
Long-term - dermal, systemic effects: 10000 mg/kg bw/day ÷ 100 = 100
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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