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EC number: 203-445-0
CAS number: 106-94-5
Only one of the four studies available for this endpoint identified a
quantitative NOAEL value which provided clear evidence of impaired
fertility as a result of exposure to n-propyl bromide. This was a
reliable study conducted to GLP using standard test methods and as such
this value has been used as the key value for effects on fertility.
Whole-body inhalation exposure of Crl:CD(SD)IGS BR rats and the
resulting offspring to vapor concentrations of 1-Bromopropane (100, 250,
500 and 750 ppm [F0 only]) for 6 hours per day, 7 days per week for a
minimum of 70 days prior to mating and continuing until euthanasia
produced no post-exposure clinical observations different from the
control group animals exposed to filtered air. There were no mortalities
related to exposure in the F0 generation. One F1 male in the 500 ppm
group was euthanised in extremis during the second week of exposure.
Body weight data (parental and pup) were reduced in the 500 (F0, F1 and
F2) and 750 ppm (F0) groups. No macroscopic or microscopic pathology in
brain tissue was observed. Complete lack of offspring was observed at
exposures to 750 ppm, and a statistically decreased number of offspring
compared to the control group was observed at exposures to 500 ppm (both
generations). Non-statistically significant reductions in the number of
offspring were observed in 250 ppm group for both generations. Fertility
indices were statistically significantly reduced for the F0 500 ppm
group. Reductions (not statistically significant) were observed in the
100, 250 and 500 ppm F1 groups. Extended estrous cycle lengths and an
increase in the number of animals for which estrous cycle length could
not be determined were observed in the 250 (F1), 500 (F0 and F1) and 750
(F0) ppm groups. The number of days between pairing and coitus were
increased in the 500 and 750 ppm F0 groups. Reductions in organ weights
were observed in the ovaries (500 and 750 ppm group F0 females),
epididymides in the 250 (F0), 500 (F0 and F1) and 750 (F0) ppm group
males, prostate (250, 500 and 750 ppm group F0 males), seminal vesicles
(500 and 750 ppm group F0 males), pituitary in the 500 (F1) and 750 (F0)
ppm group males and spleen in the F2 male and female weanlings. Organ
weight differences from the control group values were also observed in
the thymus (increase), liver (increase) and brain (decrease) in some
groups. Generally, absolute values were different in treated animals
compared to the control group values, but not when weights were
expressed relative to body weights. Absolute brain weights were in the
expected range for age, sex and strain, and no clinical or microscopic
changes were correlated with the weight differences. No pathology was
associated with the thymus weight increases, and increased lipid
vacuolation and glycogen content of the liver was considered reversible,
and not of biological significance. Spermatogenic endpoints were
adversely affected in the 500 (F0 and F1) and 750 (F0) ppm group males.
Microscopic findings were observed in the ovaries in the 500 (F0 and F1)
and 750 (F0) ppm group females.
All toxicity to reproduction studies performed on n-propyl bromide were conducted using the inhalation route of exposure as due to the physicochemical properties of the substance this is the most likely route of exposure.Two studies were available for this endpoint:Rodwell. D.E (2001) (full study): NOEL: maternal toxicity and fetal toxicity: 100 ppm; teratogenicity: 996 ppmRodwell. D.E (1999) (range finding study): NOEL: maternal toxicity: 100 ppm
Neither of the available studies for this endpoint identified a
quantitative NOAEL value. However, the studies do provide suspicion of
developmental toxicity as a result of exposure to 1-bromopropane. The
lowest NOEL value established for the developmental toxicity and
teratogenicity of 1-bromopropane is 100 ppm (equal to 503 mg/m³).
Based upon the above results, according to section 4.2.3 of Directive
67/548/EEC, the substance does meet the criteria for classification as a
substance that should be regarded as if it would impair fertility in
humans (Repr. Cat. 2; R60). In addition, the substance also meets the
criteria for classification as a substance that should be regarded as
causing concern for humans owing to possible developmental toxic effects
(Repr. Cat. 3; R63).
As such, n-propyl bromide is officially classified as Repr. Cat. 2; R60
and Repr. Cat. 3; R63 on Annex I of Directive 67/548/EEC and as a
Reproductive toxicant Category 1B on Annex VI of the EU Classification,
Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC)
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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