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EC number: 205-598-9
CAS number: 143-29-3
Rat OECD 422: NOAEL systemic toxicity = 100 mg/kg bw due to decreased
body weight, food consumption, increased liver weights and microscopic
liver changes in the higher dose (GLP, RTC/ Rohm & Haas 2004)
Rat OECD 408: NOAEL systemic toxicity = 80 mg/kg due to effects in liver
(adaptive) and kidney, severe clincal signs and deaths at higher
doseages (ERBC 2020)
no data available
no data available
The toxicity of Bis(2-(2-butoxyethoxy)ethoxy)methane in rats after oral
administration for 13 weeks and recovery from any treatment-related
effects during a period of 4 weeks, were investigated in this study,
according to OECD 408 guideline.
Three groups, each of 10 male and 10 female Sprague Dawley rats,
received the test item by gavage at dosages of 80, 240 and 800mg/kg body
weight/day for 13 consecutive weeks. A fourth similarly constituted
group received the vehicle alone (aqueous solution of
carboxymethylcellulose 0.5% w/v) and acted as a control. Five additional
animals for each sex were
included in each group for recovery assessment.
The following investigations were performed: daily clinical signs,
weekly detailed clinical signs (removal from cage and open field
observations), evaluation of sensory reactivity to stimuli and motor
activity, body weight, food consumption, ophthalmoscopy, clinical
pathology investigations (including thyroid hormone determination),
terminal bodyweight, organ weights, macroscopic observations,
Severe clinical signs (including an high incidence of mortality) were
observed at the high dose level of 800 mg/kg/day and, with lower
severity and incidence, at the mid-dose of 240 mg/kg/day.
No significant clinical signs or other signs of toxcity were observed in
animals dosed at 80 mg/kg/day during the in vivo phase of the study.
At post mortem, changes in the liver at 240 and 800 mg/kg/day were
considered to adaptive.
Atrophy of the thymus was mainly reported in high dose males and in most
females dosed at 80 mg/kg/day at the end of treatment period, with an
increased incidence and/or severity,
where compared to controls. At the end of recovery period, atrophy of
the thymus was noted in controls and some treated animals. Therefore,
this change could be considered stress-related rather than
treatment-related and, considered the high variability noted at the end
of treatment period, it is considered not adverse/significant at 80
The nephropathy observed in animals dosed at ≥ 240 mg/kg/day at the end
of treatment period showed an increase in incidence and severity in male
and female animals treated at
240 mg/kg/day at the end of recovery, when compared to controls, while
at the dose level of 80 mg/kg/day, the incidence and severity were
comparable between controls and treated
Therefore, the dose level of 80 mg/kg/day could be considered the NOAEL
(No Adverse Effect Level) in this study.
A GLP conform repeated dose/ reproductive toxicity study was performed
with TP-90B RUBBER CHEMICAL according to OECD 422 (RTC/ Rohm & Haas
2004). Groups of 10 Sprague-Dawley rats per sex received TP-90B Rubber
Chemical in 0.5% aqueous carboxymethylcellulose at doses of 10, 100 and
800 mg/kg bw/d by gavage. Males were treated for 2 weeks prior to
pairing, through pairing until the day before sacrifice. Females were
treated for 2 weeks prior to pairing, through the mating and gestation
periods up to day 3 of lactation. Dams and offspring were sacrificed on
Day 4 post-partum (= at least 43 days). Observations were made as
Fate of females
One mid dose female was sacrificed on Day 0 post-partum for human
reasons since signs of dystocia (difficult delivery) were noted.
Weekly physical examinations including detailed clinical signs and
neurotoxicity assessment (Functional Observation Battery) did not show
any treatment-related effects. Daily post-dose observations of clinical
signs showed high dose male animals with ataxia,
Semi closed eyes, hunched posture, reduced activity and salivation.
Pronation, ataxia, semiclosed eyes, reduced activity, hunched posture,
lethargy, twitches, piloerection and salivation were noted at post-dose
observations in high dose females.
Body weight and body weight gain
Slight decreases in body weight and body weight gain occurred only in
high dose females during gestation.
Food consumption remained comparable between control and treated groups
in both sexes before pairing. Reduced food consumption was noted in high
dose females on Days 7 and 14 post-coitum.
Motor activity and sensory reaction to stimuli
Motor activity measurements and sensory reaction to stimuli were
unaffected by treatment at any dose level in both sexes.
No toxicologically significant change in haematology values occurred in
males or females at any dose level.
No toxicologically significant change in any clinical chemistry
parameter occurred in malesor females at any dose level.
Terminal body weight and organ weights
No differences in terminal body weights were observed between treated
and control animals. Absolute and relative liver weights were increased
in high dose males and females when compared to controls. All changes
were statistically significantly different from controls except the
absolute liver weight in females.
No macroscopic change was reported at necropsy in the examined
organs/tissues of the animals killed at termination that could be
considered related to the administration of the test item. The gross
changes observed were considered to be incidental or spontaneous in
No microscopic changes clearly related to test item administration were
observed in male or female rats in the low and mid-dose groups. Diffuse
hepatocellular hypertrophy (enlarged hepatocytes in all areas of the
lobules) occurred in male and female rats of the high dose group. A
finding of uncertain significance was observed in the high dose group.
Focal germ cell depletion and degeneration in one testis (unilateral)
occurred in four high dose male rats. Three of these four rats also had
a few exfoliated spermatogenic cells in the lumen of the epididymal
In conclusion, following effects were observed only at the high dose
(800 mg/kg bw/ day):
- Post-dose clinical signs indicating general effects of toxicity in
males and females
- Decreased body weight and body weight gain in females during gestation
- Reduced food consumption in females on days 7 and 14 post-coitum
- Increased liver weights
- Microscopic changes in the liver
The NOAEL of this study was 100 mg/kg bw/d since increases in absolute
and relative kidney weights noted in the mid-dose male group only were
not interpreted as a clear adverse health effect as this effect was not
observed in the high-dose group.
no data available
Repeated dose toxicity: via oral route - systemic effects
(target organ) liver and kidney
Based on the available data on the repeated dose toxicity of
hexaoxatricosane no classification is warranted according to the
criteria of both, 67/548/EEC and CLP regulation (EC) 1272/2008.
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