Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 259-515-6
CAS number: 55184-72-0
Method Validation (20/027-316AN)
The purpose of this study was to
validate a High Performance Liquid Chromatography method with UV
detection (HPLC-UV) in order to determine the concentration of AEROSOL
TR-70 E Lyophilized in formulation, primarily to support OECD No. 422
study (Study code: 20/027‑220P). A secondary purpose was to determine
the stability of the test item in the required formulation under its
conditions of use and storage. The procedure was found to be suitable
for the analysis. A summary of the method parameters is presented in
Table 1. Results of the Method
The column used provides good separation with a characteristic peak selective for the test item. The UV absorption at 210 nm has a background of above zero (at ~30% of the LOQ); although the Study Plan specified 20% of the LOQ as the maximum for interfering compounds, this background peak is not considered to be an interfering compound in the test item formulations.
Since the calibration graph is corrected with the observed background signal, it is considered that the selectivity is adequate hence there is no impact on the results or integrity of the study.
Reinjection repeatability (7 injections)
0.2 – 2 mg/mLof the test item
Limit of Quantification
0.2 mg/mLof the test item
[= 1 mg/mL (test iteminPG)]
Recovery of thetest itemfromPG(~5 and~250 mg/mL)
96.0 and 97.6%
Precision inPG(~5 and~250 mg/mL)
0.4 and 0.2%
Stability of thetest iteminPGat~5 and~250 mg/mL at room temperature (1 day)
97 and 93%
Stability of thetest iteminPGat~5 and~250 mg/mL at room temperature (3 days)
98 and 93%
Stability of thetest iteminPGat~5 and~250 mg/mL at room temperature (7 days)
95 and 90%
Stability of thetest iteminPGat~5 and~250 mg/mL at 2-8°C (7 days)
Stability of the samples for at least 24 hours in the autosampler
97 and 97%
Stock solution stability for at least 7 days at 5±3 °C
purpose of this OECD No. 422 study was to obtain information on the
possible toxic effects of Sodium 1,4-diisotridecyl sulphonatosuccinate
(CAS 55184-72-0, EC 259-515-6) test item following repeated (daily)
administration by oral gavage to Wistar (Crl:WI) rats at 3 dose levels.
A control group received the vehicle only (propylene glycol).
study also comprised a reproductive/developmental toxicity screening
test, intended to provide initial information on possible effects on
male and female reproductive performance such a gonadal function, mating
behaviour, conception, pregnancy, parturition and also on the
development of the F1 offspring from conception to Day 13 post-partum.
dose levels were selected by the Sponsor in consultation with the Study
Director based on the results of a Dose Range Finding (DRF) study. Based
on those results, 1000 mg/kg bw/day was selected as the High dose for
Dose formulation concentration
Dose formulation volume
Number of animals
measured during the study included twice a day mortality checking, daily
routine and weekly detailed observation of clinical signs, weekly body
weight and food consumption measurements and clinical pathology
evaluation (including haematology, coagulation, clinical chemistry and
urinalysis). Neurological assessment (Functional Observation Battery
(FOB) including measurements of the landing foot splay, grip strength as
well as locomotor activity measurement) was performed during the last
week of the treatment for each sex. In addition, the reproductive
performance, pregnancy, parturition and postpartum/lactation period were
monitored in the adult animals, and viability, clinical signs and
development were evaluated in their F1 offspring until PND13. At
termination (Day 28 for males, PPD (Post-partum Day) 14 for females),
necropsy with macroscopic examination was performed. Weights of selected
organs were recorded, and representative tissues/organs were sampled and
preserved in appropriate fixatives from the adult animals or F1 animals.
The thyroxine (T4) levels in the PND (Post-natal Day) 13 pups and
parental males were also determined.
the adult animals, a detailed histological examination was performed on
the selected list of retained organs of 5 animals/sex in the Control and
High dose groups, all found dead animals and all those male / female
mating pairs where no liveborn pups were achieved.
formulation were analysed for concentration and/or homogeneity on four
occasions during the study. Overall, the formulations were considered
adequate for the study.
(repeated dose section only)
summary, under the conditions of this study the daily administration of
Sodium 1,4-diisotridecyl sulphonatosuccinate (CAS 55184-72-0, EC
259-515-6) by oral gavage to Wistar rats at dose levels of 100, 300 or
1000 mg/kg bw/day (Low, Mid and High dose groups, respectively) did not
result in test item related mortality or clinical signs.
item related adverse effect was observed on body weight parameters and
food consumption in High dose (1000 mg/kg bw/day) males and females
during gestation and lactation periods (no effect was seen in the
the functional observation battery (FOB) and locomotor activity
measurement, there were no changes in animal behaviour, general physical
condition or in the reactions to different type of stimuli in test item
treated groups when compared to control.
test item-related adverse effects were seen in the clinical pathology
parameters. Test item related non-adverse changes (increased Alanine
aminotransferase activity in the Mid dose males and High dose males and
females, as well as increased Alkaline phosphate activity in High dose
females) were considered to be linked to the adaptive response seen in
the liver during microscopic examination (hepatocellular hypertrophy and
vacuolation which was observed only in High dose animals, but not in Mid
or Low dose animals).
test item-related effects were observed in the organ weights of the test
item treated animals compared to controls.
of the non-glandular gastric mucosa of the stomach was identified at the
High dose level (1000 mg/kg bw/day), as test item-related adverse
change. Mid and Low dose stomach samples of both sexes were also
evaluated the get additional information for study interpretation, no
test item-related changes were seen in those animals.
indication of an endocrine disruptor effect was observed in the study
based on collected oestrus cycle data, anogenital distance measurement,
nipple retention, thyroid hormone measurement, thyroid weight and
histopathology and external reproductive organs analysis.
NOAEL for systemic toxicity of the parental generation: 300 mg/kg bw/day
(based on body weight and food consumption effects, and stomach
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.
Deze website maakt gebruik van cookies om het surfen zo aangenaam mogelijk te maken.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again