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EC number: 947-850-7 | CAS number: -
Repeated dose toxicity - oral (no OECD, 2-year study), rat: NOAEL ≥ 1000 mg/kg bw/day
Repeated dose toxicity - oral (OECD 408, 90-day), rat: NOAEL ≥ 250 mg/kg bw/day
RA from source substance Sodium N-lauroylsarcosinate (CAS 137-16-6)
Additional study considered in a Weight-of-Evidence approach:
CAS 137-16-6, Huntingdon, 1997: NOAEL (90d, rat, m/f) > 250 mg/kg bw/day
No data on repeated dose toxicity is available with Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7). Therefore, read across from the analogue substance Sodium N-lauroylsarcosinate (CAS 137-16-6) was applied with respect to the oral route. For the inhalative and the dermal route of exposure, waivers are provided (please refer to IUCLID section 7.5.2 and 7.5.3).
Repeated dose toxicity: oral
Sodium N-lauroylsarcosinate (CAS 137-16-6) was tested for chronic oral toxicity in a 2-year study in 200 rats (CIR, 2001). Groups of 25 Wistar rats per sex and dose were given 0.05, 0.2 and 1% of the test material in the diet, 7 days/week for 24 months. The concentration of the test material in the low dose group (0.05%) was increased to 2% (equiv. to 1000 mg/kg bw/day) after 6 months. A concurrent negative control group receiving the plain diet was included. At one, three and six months no significant differences were observed in mortality, body weight gain and haematology. At the end of the study period, the only consistent difference observed in the gross pathology was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test article (group 1: 2%; group 3: 1% in the diet) due to the local irritating effects of the test substance. Furthermore, fertility assessment did not show any significant differences (no further information). Based on the lack of adverse effects, a NOAEL of 1000 mg/kg bw/day (m, f) was identified in this study.
In addition, Sodium N-lauroylsarcosinate (CAS 137-16-6) was also tested for subchronic repeated dose oral toxicity in a 90-day study, conducted according to OECD TG 408 and in compliance with GLP (Huntingdon, 1997). Groups of 15 Sprague-Dawley-derived outbred albino rats per sex and dose received the test item at doses of 30, 100 and 250 mg/kg bw/day on 7 days per week for 91 or 92 days, respectively (depending on scheduled sacrifice). Concurrent negative control animals received the vehicle only (sterile, distilled water). No treatment-related mortality or clinical signs of toxicity were observed throughout the study period. Statistically significant decreased body weight gain with 7 and 9% decreased body weights at study termination compared to controls was observed for the mid- and high-dose males (100 and 250 mg/kg bw/day, respectively). In contrast, females of the same dose groups showed recognizable, but statistically not significant lower body weight gain with 4% decreased body weights at necropsy compared to controls. Since animals still gained weight, and the decrease of body weight in comparison to the controls was < 10%, this effect is considered to be not adverse. At necropsy, increased absolute stomach weights, stomach/body and stomach/brain weight ratios were noted in both males and females of the 100 and 250 mg/kg bw/day dose groups. All differences were statistically significant, except for absolute stomach weight in mid-dose females. The effect was associated with increased stomach wall thickness and yellow discolouration of non-glandular gastric mucosa. Histopathological examination revealed increased incidence and severity of squamous cell hyperplasia, hyperkeratosis/parakeratosis, inflammation and edema of the non-glandular gastric mucosa of both males and females in these dose groups. No effects were observed in low-dose animals (30 mg/kg bw/day). Since this effect was noted in a dose-related manner, it is considered to be treatment-related. However, the effects reported were localized to the stomach only, reflecting the irritant characteristics of the test substance, and no further signs of systemic toxicity were observed in any of the animals in any dose-group throughout the study period. Thus, the NOEL of this study is 30 mg/kg bw/day, the LOAEL for local effects in the stomach is 100 mg/kg bw/day, and the systemic NOAEL was set to ≥ 250 mg/kg bw/day.
In summary, a 2-year oral and a subchronic oral study with Sodium N-lauroylsarcosinate (CAS 137-16-6) showed no adverse systemic effects resulting in NOAELs of ≥ 250 derived from the subchronic study and 1000 mg/kg bw/day derived from the chronic study. Since the NOAEL of 1000 mg/kg bw/day was derived from the study with the longest study duration and no adverse effect was observed in the subchronic study up to and including the highest dose of 250 mg/kg bw/day tested, the higher value is considered to be the most reliable dose descriptor. Thus, based on read-across, a NOAEL of 1000 mg/kg bw/day after chronic oral application is concluded for the registered substance.
With respect to repeated dose toxicity, the available data from the read-across substance Sodium N-lauroylsarcosinate (CAS 137-16-6) indicate no hazard and do not meet the criteria for classification for any hazard class, e.g. target organ toxicity, according to Regulation (EC) No. 1272/2008 (CLP). Therefore, applying the read-across approach, the registered substance Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7) is also considered not to meet the criteria for classification.
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