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EC number: 266-840-7
CAS number: 67656-24-0
Weight of Evidence approach for oral acute toxicity: OECD 401, rat: LD50
> 1232 mg/kg bw, OECD 422 study in rats: NOAEL >= 1000 mg/kg bw/day,
QSAR: low acute toxicity
Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw
Acute toxicity: oral
In an acute oral toxicity study (similar to OECD 401) 5 male and female
rats received a 50% solution of Butylmonoglycol sulphate, Na-salt (CAS
67656 -24 -0) at 3000 mg/kg bw (Hüls AG, 1987). No mortality occurred at
a dose level of 3000 mg/kg bw in neither males nor females. No clinical
signs of toxicity were observed up to the end of the 14-day observation
period and there were no adverse effects on body weight gain. Necropsy
revealed no substance-related findings. In summary, the acute oral LD50
value for male and female rats was considered to be > 3000 mg/kg bw for
the 50% solution. Recalculation to the neat test substance would result
in an LD50 of > 1232 mg/kg bw. Thus, the limit dose of 2000 mg/kg bw was
not reached and a final conclusion on the classification cannot be drawn.
Therefore, a weight of evidence approach with additional sub-acute test
data and QSAR data is performed in order to sufficiently cover the data
requirements. An OECD 422 guideline study in compliance with GLP in rats
is available (Toxi-Coop, 2018). Butylmonoglycol sulphate, Na-salt was
administered orally (by gavage) once daily at doses of 0 (vehicle only),
100, 300 and 1000 mg/kg body weight/day to four groups of Han:WIST of
Wistar origin rats consisting of 17 animals per sex in the control and
high dose and 12 animals per group in low and mid dose group. A group of
vehicle (distilled water) treated animals (n = 17/sex) served as
control. All animals of the parent (P) generation were dosed prior to
mating (14 days) and throughout mating. In addition, males received the
test item or vehicle after mating up to the day before necropsy
(altogether for 49 days). Females were additionally exposed through the
gestation period and up to lactation days 13-16, i.e. up to the day
before necropsy (altogether for 50, 51, 52, 54, 55 or 56 days). Animals
of the recovery groups were administered for 63 days. There was no
mortality in control, 100, 300 or 1000 mg/kg bw/day groups during the
course of study (male and female). Clinical signs of systemic toxicity
related to the test item were not detected at any dose level at the
daily or weekly detailed clinical observations or at the terminal
functional observations. The behavior and physical condition of animals
was not affected by the test item at any dose level (100, 300 or 1000
mg/kg bw/day) during the entire observation period. The body weight
development of parental animals (male and female) was not affected by
the test item during the course of the pre-mating, mating, post-mating,
gestation and lactation periods, as well as during the recovery period.
The mean daily food consumption was not affected by the test item in
male or female animals at 100, 300 and 1000 mg/kg bw/day during the
entire study (pre-mating, post-mating, gestation and lactation periods,
as well as recovery period). Hematological evaluation did not reveal
adverse test item related changes in the examined parameters at 100, 300
or 1000 mg/kg bw/day (treatment and the recovery periods). There were no
test item related adverse effects on the examined clinical chemistry
parameters at any dose (male or female; treatment and the recovery
periods). There were no test item related changes in the serum thyroid
hormone (T4 and TSH) levels at any dose (parental male and 13-day
offspring). Macroscopic findings related to the effect of the test item
were not found in male and female animals at 100, 300 or 1000 mg/kg
bw/day (treatment and the recovery periods).
There were no test item related changes in the weights (absolute and
relative to body or brain weights) of brain, testes and epididymides of
male animals at any dose level.
The absolute and relative weights of examined organs did not demonstrate
any test item related adverse alterations in selected animals (treatment
and the recovery periods).
Histopathological examinations of the selected organs (ovaries, uterus,
vagina, testes, epididymides, prostate and seminal vesicles with
coagulating gland) did not reveal any test item related changes at 1000
There were no pathologic changes in the examined organs or tissues of
randomly selected male or female animals in the control or 1000 mg/kg
bw/day groups (treatment and the recovery periods).
In conclusion, an acute oral toxicity study tested up to 1232 mg
butylmonoglycol sulphate, Na-salt/kg bw did not show any signs of
toxicity. Furthermore, in a sub-acute toxicity study no toxicity was
observed up to the highest dose tested (NOAEL >= 1000 mg/kg bw/day).
Finally, the acute oral toxicity potential of 2 -butoxyethyl sulphate
was evaluated using OECD QSAR Toolbox v4.2. Profilers on toxic hazard
classification by Cramer indicated low acute toxicity (Class I). Based
on the QSAR profiling no acute oral toxicity is expected for
2-butoxyethyl hydrogen sulphate. Taken all data together, it can be
concluded that butylmonoglycol sulphate, Na-salt is not acute toxic
after oral exposure.
Acute toxicity: dermal
An acute dermal toxicity study is available for the registration
substance Butylmonoglycol sulphate, Na-salt (CAS 67656-24-0) which was
conducted according to OECD TG 402 (Toxi-Coop, 2017). In this GLP study,
a single group of male and female animals (n=5 animals/sex) exposed to
the test material at a dose of 2000 mg/kg bw. No mortality occurred at a
dose level of 2000 mg/kg bw in neither male nor females. No clinical
signs of toxicity were recorded during the study period. No behavioral
changes and no systemic toxic signs were noted during the study. The
test item did not cause dermal irritation symptoms. In summary, the
acute dermal LD50 value for male and female rats was considered to be >
2000 mg/kg bw.
The available data on acute toxicity of butylmonoglycol sulphate,
Na-salt do not meet the criteria for classification according to
Regulation (EC) No 1272/2008, and are therefore conclusive but not
sufficient for classification.
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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