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EC number: 205-739-4
CAS number: 149-44-0
Two females receiving 600 mg/kg/day were found dead on Day 50 of the
treatment period of the
study. The changes observed at macroscopic and microscopic pathology did
not give any
indication of the cause of death of these animals.
No significant signs of toxic or neurotoxic effects were seen during the
“in-life” phase of the study.
No lesions were recorded at ophthalmological examination.
No changes of toxicological relevance were observed in haematological,
coagulation and urine
Minor fluctuations of clinical chemistry parameters were recorded in
animals dosed with 250
and/or 600 mg/kg/day. The majority of the above changes were reversible
at the end of the
No treatment-related findings were reported at post mortem observations
and at histopatological
The toxicity of Sodium Hydroxymethansulfinate was investigated in Wistar
Hannover rats after
daily oral administration for 13 weeks and recovery from any
treatment-related effects during a
recovery period of 4 weeks.
Three groups, each of 10 male and 10 female Sprague Dawley rats,
received the test item by
gavage at dosages of 100, 250 and 600 mg/kg/day for 13 consecutive
weeks. A fourth similarly
constituted group received the vehicle alone (purified water) and acted
as a control. Five
additional animals for each sex were included in the high dose and
control groups for recovery
The following investigations were performed: daily clinical signs,
weekly detailed (open field
observations) clinical signs, evaluation of sensory reactivity to
stimuli and motor activity, body
weight, food consumption, ophthalmoscopy, clinical pathology
investigations, terminal body
weight, organ weights, macroscopic observations and histopathological
Mortality and daily clinical signs
study (Nos. 95750085 and 95750089). No clinical signs or other signs of
toxicity were observed in
these animals up to death.
The changes observed at macroscopic and microscopic pathology did not
give any indication of
the cause of death of these animals.
Daily clinical signs in surviving animals were limited to slight
skin/fur staining of the ventral region,
seen in the majority of the animals dosed at 600 mg/kg/day during the
last five days of treatment
period and during the duration of recovery period.
Weekly detailed clinical signs (open field measurements)
No changes of note were found at the weekly clinical examination which
included an evaluation of
Sensory reactivity to stimuli and motor activity
No differences between treated animals and controls which could be
considered of toxicological
relevance were observed at evaluations of sensory reaction and motor
performed at the end of treatment and recovery periods.
Body weight and body weight changes
No significant differences in body weights were noted between treated
animals and controls during
Statistically significant body weight reductions were observed in the
high dose females on Days 1
and 8 of recovery.
Body weight changes were occasionally slightly reduced in the high dose
treatment and recovery periods.
Food consumption was not affected by treatment.
No treatment-related findings were seen at the ophthalmic examination.
No changes of toxicological relevance were observed during the treatment
and recovery periods
of the study.
Some statistically significant fluctuations of biochemical parameters
(increases of urea and
calcium, decrease of creatinine in males from the low and/or high dose
groups, decreases of
glucose and increase of phosphorus in females from the low and/or high
dose groups) were
observed at the end of treatment.
No other treatment-related changes were observed.
The changes recorded during the dosing phase showed an almost complete
No changes of toxicological relevance were recorded at the end of
treatment and recovery
Terminal body weight and organ weights
No changes which could be considered of toxicological relevance were
observed at the end of
Final and recovery sacrifice
Treatment-related changes were noted in the ventral abdomen of the
animals dosed at 600
mg/kg/day, consisting of yellowing staining.
No apparent treatment-related changes were noted.
On the basis of the above results, only minor signs of possible
treatment-related effects of the test
item, Sodium Hydroxymethansulfinate, were observed in male and female
rats at the dose levels
of 250 and 600 mg/kg/day, when administered by oral gavage for 13
consecutive weeks at the
dosages of 100, 250 and 600 mg/kg/day.
These effects included minor clinical signs, slight reductions in body
weight gain (high dose
females) and some fluctuations in clinical pathology parameters, mainly
observed in the animals
dosed at 600 mg/kg/day. These changes were generally fully reversible
and, as such, they were
not considered to be adverse.
No changes were observed in the animals dosed at 100 mg/kg/day.
Therefore, it can be concluded that the No Observed Adverse Effect Level
(NOAEL) for this study
was 600 mg/kg/day and the No Observed Effect Level (NOEL) was 100
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