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EC number: -
CAS number: -
Physical data as well as information from toxicological data indicate
that Reaction mass of N-butylphthalimide and N-sec-butylphthalimide and
N-propylphthalimide is absorbed and metabolized in the body.
Furthermore, there are no indications for accumulation and the substance
or its metabolites are likely eliminated from the body.
A toxicokinetic assessment based on the physical properties (see ECHA
Guidance on Information Requirements and Chemical Safety Assessment,
R7c, version 3.0, June 2017) and toxicity data was performed. NOTE: this
is mostly a generic assessment based on general statements in the
guidance document that are derived from physical parameters.
The substance is an organic multi-constituent substance consisting of
the three main constituents N butylphthalimide (BP, CAS No 1515-72-6, 56
% w/w), N sec butylphthalimide (SBP, CAS No 10108-61-9, 31 % w/w) and N
propylphthalimide (PP, CAS No 5323-50-2, 14 % w/w).
Based on the low molecular weight (BP: 203 g/mol, SBP: 203 g/mol, PP:
189 g/mol), low water solubility (below 200 mg/l) and moderate log P
values (2.5-3.1) of the three main constituents of the substance,
absorption through aqueous pores or bulk passage with water through the
epithelial barrier and absorption by passive diffusion is possible. The
structure of all three constituents (BP, SBP and PP: 2 Carbonyl groups
each) suggest that the compounds may be ionized which could hinder their
ability to diffuse across biological membranes.
In a combined repeated dose toxicity study with the reproduction/
developmental toxicity screening the substance administered at 50, 100
or 300 mg/kg bw/day by oral gavage did not cause signs of systemic
toxicity and did not adversely influence the reproductive performance
(gonad function, mating behavior, conception, parturition) in parental
male and female Hsd.Han: Wistar rats (NOAEL: 300 mg/kg bw/d). Further,
the development of the F1 offspring was not impaired from birth to
post-natal day 13 at any dose level after repeated oral administration
of dams (NOAEL: 300 mg/kg bw/d).
Various oral acute toxicity test showed high lethality at the dose of
=2000 mg/kg bw of the substance. Common clinical symptoms are adverse
effects on the CNS (loss of righting reflex, coma, lethargy, ptosis),
decreased respiratory rate as well as disturbances of autonomic
functions across all doses (increasing with higher doses). All effects
were reversible starting one to five days after treatment. These
findings suggest that that some of the main constituents are absorbed.
Due to the low volatility (3 Pa) and high boiling point (303°C) the
substance is not present in a gaseous state and absorption through
inhalation is therefore unlikely. If the substance should still reach
the respiratory tract, the moderate log P values of the main
constituents suggest that they can cross the alveolar and capillary
membranes by passive diffusion. There is no toxicity data available via
inhalation but results from acute oral toxicity studies suggest that
absorption is likely if the substance is inhaled.
Physical data like physical state (liquid) and medium molecular weight
of the main constituents (range between 100 and 500 g/mol) indicate that
absorption of the substance via the skin is possible. The water
solubility (75-154 mg/l) of the main constituents suggest that dermal
uptake of the substance is low to moderate. Although water solubility is
low, the log P values between 1 and 4 favor dermal absorption (the
values of the main constituents are even considered optimal for dermal
absorption). The low vapor pressure (3 Pa at 20°C) of the substance
indicates low evaporation resulting in a potentially higher dermal
absorption. Animals in the skin irritation test showed no clinical signs
regarding corrosion. Additional dermal toxicity data for the substance
is currently not available (04/2018: study in progress).
Based on the relatively small size of the main constituents wide
diffusive distribution in the body is expected. Based on the log P
values (2.5-3.1) distribution into cells is expected. Acute oral
toxicity studies have shown effects on the central nervous system (CNS)
which indicates that the substances (and/or its metabolites) have
distributed to the CNS.
None of the substances have a log P value greater than 4 and are
therefore unlikely to accumulate in the lipid rich stratum corneum;
substances with a log P value <3 are not likely to accumulate in the
adipose tissue with the repeated intermittent exposure patterns normally
encountered in the workplace but may accumulate if exposures are
continuous. Once exposure to the substance stops, the substance will be
gradually eliminated at a rate dependent on the half-life of the
There is no experimental data available on the metabolism of the
Even though water solubility is low, the low molecular weight (<300) and
possible ionization suggest that elimination via the urine is the most
likely pathway of excretion. Based on the low molecular weight of the
main constituent excretion via the bile is unlikely. Data from acute
oral toxicity studies show that adverse effects are reversible starting
one day after treatment which could be due to metabolism or fast
excretion of the main constituents. Further information about potential
excretion pathways of the substance is not available.
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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