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EC number: 425-200-9
CAS number: 188570-78-7
The daily oral (gavage) administration of Montaverdi, a fragrance
ingredient used in household products such as fabric conditioners, to
Cr1:CD® (SD)IGS BR rats at dosages up to 400 mg/kg/day was tolerated
with no death; treatment at 1000 mg/kg/day was not tolerated with the
death of all animals.
Although over the 7-day treatment period a dosage of 400 mg/kg/day was
tolerated the presence of post-dose underactivity (a sign also seen at
1000 mg/kg/day which contributed to the early termination of that group)
in all males on the last day of treatment, is an indication that over a
longer period of dosing (such as 28 days) 400 mg/kg/day may not be
tolerated. On this basis either an additional preliminary study should
be performed to assess a suitable level for a 28-day study or the high
level for such a study should be closer to 150 mg/kg/day.
If an additional study was performed, a suitable design would be: a
single sex (males would be recommended, as this sex receiving 400
mg/kg/day showed post dosing signs prior to termination), up to three
treatment levels (possible dose levels could be 150, 300 and 400
mg/kg/day) and a longer duration of treatment up to 14 days, this would
enable further assessment of the potential for a delayed response.
In conclusion, based on data from this 7 day repeat dose toxicity study
a suitable high level for a 28-day toxicity study should be below 400
mg/kg/day, a level closer to 150 mg/kg/day than 400 mg/kg/day may be
The systemic toxic potential of Montaverdi (a fragrance ingredient used
in household products such as fabric conditioners), to Crl:cn® (SD)IGS
BR rats by oral administration was assessed over a period of seven days.
Three groups, each comprising three male and three female rats received
Montaverdi at dosages of 150, 400 or 1000 mg/kg/day. On Day 3 of
treatment all animals receiving 1000 mg/kg/day were killed due to the
excessive signs of reaction to treatment. Signs of reaction to treatment
included underactive behaviour, shallow breathing, piloerect coat,
partially closed eyes and unsteady/prostrate posture, these signs did
not show any evidence of resolution and approximately 3 hours after
dosing animals were found to have little or no righting or pinch reflex.
In addition the animals from this treatment-level were showing
bodyweight loss and low food consumption. Macroscopic examination
revealed small thymus and spleen, pale thymus, kidneys and liver and
changes in the stomach. Signs of reaction to treatment in animals
receiving 400 mg/kg/day were confined to post-dose underactivity in all
males on the last day of treatment (Day 7) and post-dose salivation on a
single occasion for 2 animals of each sex. Signs of reaction to
treatment in animals receiving 1000 mg/kg/day started on Day 1 with most
animals showing a piloerect coat approximately 1 to 2 hours after
dosing. On Day 2 post-dosing signs were seen at the end of the working
day, they included piloerection, underactivity, shallow breathing and
partially closed eyelids. On Day 3 of treatment these signs although not
present prior to dosing became apparent 1-2 hours after dosing and were
considered more severe in nature (including no righting reflex and
unconsciousness). Signs showed no resolution and at approximately 5
hours after dosing animals were moribund, necessitating premature
sacrifice. Bodyweight gains were as anticipated for animals receiving
150 or 400 mg/kg/day but were low for animals receiving 1000 mg/kg/day,
with all animals receiving 1000 mg/kg/day showing a loss of at least 20
g. Food consumption was as anticipated for animals receiving 150
mg/kg/day but was slightly low for animals receiving 400 mg/kg/day and
markedly low for animals receiving 1000 mg/kg/day. There was no visual
effect on water consumption for any animals during the treatment period.
There were no marked changes in organ weights observed in animals given
150 or 400 mg/kg/day, however spleen weights were lower for all animals
given 1000 mg/kg/day. Animals given 150 or 400 mg/kg/day showed no
macroscopic abnormalities after 7 days of treatment. In conclusion,
based on data from this 7 day repeat dose toxicity study a suitable high
level for a subsequent 28-day toxicity study (Huntingdon Life Sciences
Study Number IFF/0336) should be below 400 mg/kg/day, a level closer to
150 mg/kg/day than 400 mg/kg/day may be suitable.
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