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EC number: 215-559-8
CAS number: 1331-61-9
No repeated dose toxicity data are available for the substance.. The
endpoint's requirement was addressed with information from LAS Na. There
are three studies with LAS Na: the lowest LOAEL is from the 6-month rat
study (Yoneyama et al., 1972) with a LOAEL of 115 mg/kg bw. The highest
NOAEL below this LOAEL is from the 9-month rat study (Yoneyama et al.,
1976) with NOAEL = 85 mg/kg bw, based on histological changes seen in
the kidney. Based on the data from all the studies, an overall NOAEL of
85 mg/kg bw was considered as the most releveant, derived from a 9-
month oral study and corresponding to the NOAEL closest to the lowest
oral LOAEL of 115 mg/kg bw.
No information is available on the repeated dose toxicity
of LAS IPA. The endpoint was addressed with data from LAS Na and IPA.
Male and female rats were exposed to LAS Na (125, 250, 500 mg/kg
bw/day) orally by gavage daily for 28 days. The results showed
suppressed body weight gain, differences in some serum biochemical
measures when compared to the controls, and decreased (spleen, heart,
thymus) or increased (liver) organ weights in the animals of the highest
dose level. The resultant LOAEL and NOAEL values were 250 and 125 mg/kg
bw/day, respectively (Ito et al., 1978).
In a 6-month toxicity test male and female rats were exposed to LAS Na
(CAS 69669-44-9) in the diet daily: 40, 115, 340, 1030 mg/kg bw/day.
Diarrhea, suppressed growth, increased cecal weight, and degeneration of
renal tubes characterized the highest dose group. Similar but less
severe signs were seen in other doses with the exception of the lowest
dose of 0.07%, which showed no adverse effects related to exposure to
LAS. The resultant LOAEL and NOAEL values were 115 and 40 mg/kg bw/day,
respectively (Yoneyama et al., 1972).
In a 9-month toxicity study male and female rats were exposed to LAS Na
(CAS 69669-44-9; 85, 145, 430 mg/kg bw/day) in drinking water daily.
Body weight was suppressed in the highest dose. Significant decreases in
transaminase activity and renal Na,K-ATPase was seen in the second
group. The resultant LOAEL and NOAEL values were 145 and 85 mg/kg
bw/day, respectively (Yoneyama et al., 1976).
Information for IPA are only available
in this 90 -day inhalation study. Male and female Sprague-Dawley rats
were dosed for 6 hrs/day, 5 days/wk for approximately 13 weeks with
ispropylamine (IPA) vapours, at analytical exposure concentrations of
20, 101, and 499 mg IPA per cubic meter in air. The results revealed
reduced mean body weights of male animals in the high exposure group
throughout most of the study period. The only significant change in
hematology and clinical chemistry values, which were considered
treatment-related was a decrease in serum glucose (high dose group
females). No treatment-related gross pathological changes were
detected.The only relevant microscopic change observed was inflammation
of the nasal mucosa in females tested with 499 mg/m3. The NOAEC of the
study was set at 100 mg/m3.
Extrapolating the inhalatory NOAEC to an oral NOAEL with a sRV for rats
of 0.29 mg/m3 (for a 6 -h exposure), and with a pulmonary absorption at
least as great as absorption across the GI tract, the oral NOAEL for IPA
will be 29 mg/kg bw. Extrapolation from the inhalation to the oral route
is not likely to underestimate toxicity and therefore, it is considered
The molecular conversion of
this NOAEL to a NOAEL for LAS IPA leads to a value of 189 mg/kg bw,
which is much higher than the 85 mg/kg bw proposed for LAS Na (94 mg/kg
bw after molar scaling). Therefore, the NOAEL of 85 mg/kg bw/day (94
mg/kg bw after scaling) recorded in the 9-month feeding repeated-dose
oral toxicity study for LAS-Na was selected, as the NOAEL for LAS IPA.
Justification for selection of repeated dose toxicity via oral route
- systemic effects endpoint:
There are three repeated dose oral toxicity studies with LAS Na. The
lowest LOAEL is from the 6-month rat study (Yoneyama et al., 1972) with
a LOAEL of 115 mg/kg bw. The highest NOAEL below this LOAEL is from the
9-month rat study (Yoneyama et al., 1976) with NOAEL = 85 mg/kg bw,
based on histological changes seen in the kidney. In view of the
available information it is not possible to determine which single study
among those is the most reliable or appropriate for the determination of
a NOAEL. Therefore, based on the data from all the studies, an overall
NOAEL of 85 mg/kg bw is proposed, which was derived from a 9- month oral
study and corresponds to the NOAEL, which is closest to the lowest
available oral LOAEL of 115 mg/kg bw. No oral repeated-dose toxicity
studies are available for LAS IPA, or IPA
Justification for selection of repeated dose toxicity inhalation -
systemic effects endpoint:
The only 90-day toxicity study available for IPA is via the inhalative
route. The only histological treatment related adverse effect observed
was a local effect on the nose, that is expected to be caused by
isopropylamine (free amine) and not to the ammonium cation. Other
effects seen were decreased body weights and decreased serum glucose in
high level female animals, as well as increases in the adrenal weights.
The NOAEC of the study for the systemic effects of IPA is set at 100
Justification for selection of repeated dose toxicity inhalation -
local effects endpoint:
Repeated dose toxicity: via oral route - systemic effects (target
organ) digestive: cecum; urogenital: kidneys
Based on the results of the repeated dose
toxicity studies, LAS IPA does not warrant for a STOT classification
according to (CLP) Regulation (EC) No. 1272/2008 .
Although adverse effects have been seen after repeated exposures of
animals to LAS Na, and IPA, these were seen at dose levels above the
classification criterion limit of 100 mg/kg bw (lowest LOAEL observed
for LAS Na was 115 mg/kg bw).
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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