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EC number: 290-836-4
CAS number: 90268-36-3
were based upon following source information:
A combined repeated dose and reproductive/developmental screening study
was performed with registered substance according to OECD guideline 422
(Hansen, 2013). The test item was a solid formulation (containing >93%
active ingredient) which was administered as a watery solution orally by
gavage to rats at dose levels of 60, 120 and 300 mg act. ingr./kg bw/day
for at least 28 days in male rats up to 54 days in female rats. One of
10 male and one of 10 female animals at300 mg/kg b.w./day died
prematurely on test day 33 or on gestation day 9. Slight to moderate
salivation was noted in a few male and female animals at 120 mg/kg bw/
day; at 300 mg/kg bw/day, piloerection and a slight to extreme
salivation was noted for several to all male and female animals on
several days. Reduced body weight was noted for the male animals at
120 mg/kg bw/day and for both sexes at 300 mg/kg bw/day. Increases in
ALAT, aP and ASAT and decreases in globulin, cholesterol, chloride and
potassium concentrations were noted for the male and/or female animals
of the intermediate and/or the high dose group (120 and/or 300 mg/kg
bw/day).Several organ weights were seen in males and females dosed at120
and 300 mg/kg bw/day, most remarkably for the thymus and liver weights
of the animals of the high dose group. Macroscopic inspection revealed
changes in the stomach of male animals dosed at 300 mg/kg bw/day and
female animals dosed at 120 and 300 mg/kg bw/day. Histopathological
examination revealed changes in the liver (hepatocellular hypertrophy
and macrovesicular vacuolation) and the non-glandular stomach (squamous
cell hyperplasia) of male and female animals dosed at 300 mg/kg bw/day.
These latter changes are considered to be related to a local activity of
the test item. As humans lack a forestomach, the relevance of these
changes for humans is questionable.
were as follows: 60 mg/kg bw for paternal/maternal toxicity, 120 mg/kg
bw for reproductive toxicity (based on reduced gestation index, birth
index, live birth index and increased post implantation loss at the high
dose levels) and 120 mg/kg bw for developmental toxicity (based on a
reduced viability index at the high dose levels).The reproductive and
developmental changes were seen at paternal/maternal toxic doses, and
were considered to be secondary to that toxicity.
A 90-day study was not available for the registered substance, however
read across data were available from read-across substance in the same
subgroup, CAS No. 37294-49-8 (disodium C-isodecyl sulphonatosuccinate).
This key study for subchronic toxicity was performed in rats with test
item containing ca. 50% active ingredient (Tegeris and Underwood, 1975)
at 0.25%, 1.00% and 4.00% in the diet (corresponding to mean calculated
test article intake of 188, 750 and 3000 mg act.ingr./kg bw/day). At the
highest dose levels, it caused a significant difference in body weight
gain, most probably related to an effect by the compound during
absorption from the gastro-intestinal tract. There was one mortality in
the high dosed females. Haematology and serum analysis also indicated
toxicity at the high dose, whereas at the medium dose, only some
organ-to-body weight changes were observed (e.g. liver weight increases
in both sexes). Other organ-to-body weight changes were also observed at
the high dose group (e.g. slightly decreased gonad weights in males;
decreased gonad weight in females); increased relative kidney weights
were observed in all female dose groups. Chronic renal disease (mild)
was observed in 1/20 males and 6/20 females of the high dose groups. The
high dose was considered to be toxic, whereas the changes of the medium
dose may be considered adaptive. Therefore 1% (750 mg/kg bw/day) may be
considered as NOAEL.
For risk assessment, the lowest NOAEL of 60 mg/kg bw with registered
substance tested in the OECD 422 study was selected as dose descriptor
for calculation of long term systemic DNELS. This approach was
considered conservative, as the NOAEL with read across substance in
subchronic study with dietary administration was much higher. Further
justification of assessment factors is explained in the DNEL
justification document attached to the endpoint summary.
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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