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EC number: 205-281-5 | CAS number: 137-16-6
Acute Oral: LD50 = 5000 mg/kg bw (OECD 401)Acute inhalation LC50 (4h): 50 mg/m³
Table 1. Test atmosphere characterisation.
(mg/L; mean ± sd)
Generation efficiency (%)
5.4 ± 0.6
1.2 ± 0.1
0.6 ± 0.2
0.06 ± 0.01
Table 2. Particle Size.
(mg/L) (measurement no.)
MMAD: Mass Medium Aerodynamic Diameter
gsd: geometric standard deviation
Table 3. Table for acute inhalation toxicity.
Target concentration[mg/L air]
Duration of clinical signs
Time of death
1-1.5 h after start of exposure
2 h after start of exposure
2-4.5 h after start of exposure
LC50 0.05-0.5 mg/L air
*first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
The acute toxicity via the oral route of Sodium N-lauroylsarcosinate (CAS 137-16-6) has been investigated in rats in accordance with OECD guideline 401 under GLP conditions (Toxicol Laboratories Ltd, 1987a, AOT).
A group of 10 Sprague Dawley rats (5 males and 5 females) was treated with the limit dose of 5000 mg/kg bw of the test substance by gavage. The observation period following administration was 14 days. During the study period, one female animal died at Day 2. No clinical signs of toxicity were observed in the surviving animals. All surviving animals showed normal body weight gain. The female animal found dead had been cannibalised and autolysed. Thus, no detailed post-mortem examination was possible. In surviving animals no abnormalities were noted at necropsy.
Thus, the oral LD50 for male and female rats is greater than 5000 mg/kg bw.
Two studies are available to investigate the acute inhalation toxicity potential of Sodium N-lauroylsarcosinate (CAS 137-16-6).
In the first available study (Notox B.V., 2010a, AIT), conducted according to OECD guideline 403 and in compliance with GLP, Wistar rats were treated with the neat test material (96.2% purity) via nose-only inhalation exposure for 4 h. 5 males and 5 females each were exposed to concentrations of 5 and 1 mg/L, and 5 males each were exposed to concentrations of 0.55 and 0.055 mg/L. The powdered test material was fed to a stream of pressurised air to generate the test atmosphere. The animals were observed for mortality, clinical signs and effects on body weights for a period of 14 days following administration. At study termination, the animals were submitted to gross pathological examination. All animals of the 5 and 1 mg/L dose groups died within 1-2 h post-exposure. At 0.5 mg/L 4/5 males died within 1-2 days post-exposure. No mortality was noted in the low dose group (0.05 mg/L) throughout the study period. During exposure, animals of the 1 mg/L dose group showed laboured respiration. No clinical signs were noted during exposure in any animal of the remaining dose groups. After exposure, animals treated with 5 mg/L showed no clinical signs prior to death/sacrifice. At 1 mg/L lethargy, flat/hunched posture, laboured respiration, piloerection and red discolouration of the mouth and nose was noted among most females. No clinical signs were observed among males. At 0.5 mg/L lethargy, flat/hunched posture, laboured respiration, piloerection and red discolouration of the nose, and/or moribund condition was reported for males. No clinical signs were noted in males treated with 0.05 mg/L test material. Significant weight loss was observed for the single surviving male at 0.5 mg/L between Days 1 and 4. Body weight gain of males at 0.05 mg/L was within the range expected for rats of this strain and age used in this type of study. Gross pathology revealed red foci on the lungs, red contents of the small intestines/ileum, red discolouration of the thymus and or small intestines among most animals exposed to 5 mg/L. All animals of the 1 mg/L dose group showed red foci on the lungs or red discolouration of the lungs. Red foci on the lungs and/or thymus and/or red discolouration of the lungs were noted among most males treated with 0.5 mg/L test material. No abnormalities were noted in males exposed to a concentration of 0.05 mg/L. Based on the result of this study, the LC50 for both males and females for the neat, pulverised test substance was 0.05-0.5 mg/L. The neat test material meets therefore the criteria to be classified for acute inhalation toxicity Cat. 2, H330 according to Regulation (EC) No 1272/2008.
The second available study (WIL Research Europe B.V., 2013, AIT) was performed according to the OECD test guideline 403 and in compliance with GLP. Five Wistar rats per sex per dose were exposed to an aerosol of a 34.5% aqueous solution of Sodium N-lauroylsarcosinate (CAS 137-16-6) in a nose-only inhalation apparatus for 4 h. To generate the test atmosphere at concentrations of 0.5, 1 and 5 mg/L, the test material was nebulised and diluted with pressurised air, before entering the exposure chamber. Following treatment, the animals were observed for a period of 14 days following administration. Additionally to the recommended observations and examinations (mortality, clinical signs, body weights, gross pathology), histopathological examination of low and high dose animals was performed with special focus on the respiratory tract in order to consider the influence of the well-known irritant characteristics of the test substance on the results. No mortality occurred after exposure to 0.5 or 1 mg/L. At 5 mg/L, two females and three males were found dead immediately following the exposure, and the remaining animals were sacrificed for humane reasons within 1 hour after exposure. No further mortalities occurred throughout the study period. Clinical signs noted during exposure with 0.5 mg/L were shallow respiration in all animals. After exposure, the only clinical sign noted was the chromodacryorrhoea of the snout in one male on Day 2. At 1 mg/L, shallow respiration was noted in all animals during exposure. After exposure, hunched posture, slow breathing and/or piloerection was noted among all animals between Days 1 and 3. Slow breathing and laboured respiration were seen in all animals during treatment with 5 mg/L. After exposure, lethargy, hunched posture, slow breathing, laboured respiration and/or piloerection were observed in the animals that were sacrificed for humane reasons on the day of exposure. The overall body weight gain in surviving males and females was within the range expected for rats of this strain and age used in this type of study. Macroscopic post mortem examination of the animals revealed the following findings that were considered to be treatment-related: at 5 mg/L lungs with watery cloudy content were noted in 1/5 males and 4/5 females; the microscopic correlate was alveolar fibrinous material. The thymus was found to be dark red or with reddish foci in 5/5 males and 5/5 females; the microscopic correlate was congestion. The mandibular lymph nodes showed reddish discolouration in 3/5 males and 2/5 females; the microscopic correlate was congestion and erythrophagocytosis. In animals exposed to 1 mg/L the thymuses were found with reddish discolouration and dark red foci in 1/5 males and 1/5 females. The lung was reddish discoloured in 1/5 males. At 0.5 mg/L no treatment related findings were noted. Histopathological examination revealed local effects on the respiratory tract. Erosion in the trachea was present in one female treated with 0.5 mg/L at minimal degree and in most males and all females treated with 5 mg/L up to marked degree. Epithelial degeneration of the trachea with loss of cilia was present in all males and females treated with 5 mg/L up to moderate degree. Trachea ulceration was present in one male exposed to 5 mg/L at slight degree. Perivascular oedema of the lung was present in one female treated with 0.5 mg/L at slight degree and in most males and females of the 5 mg/L dose group up to moderate degree. Alveolar ectasia of the lung was present in one female treated with 0.5 mg/L at minimal degree and in all males and some females exposed to 5 mg/L at minimal degrees. All males and females treated with 5 mg/L showed alveolar fibrinous material in the lungs up to moderate degree. Epithelial necrosis of the larynx was noted in all males and females treated with 5 mg/L at marked degree; and granulocytic inflammation of the larynx up to slight degree was reported for all males and females exposed to 5 mg/L. Epithelial necrosis of the nasal pharynx (nasopharynx) up to massive degree was present in all males and females treated with 5 mg/L. The findings in the rats of the 5 mg/L dose group were considered to be markers of acute respiratory tract irritancy caused by the test item. The lack of findings in the males, and the few remaining lung and trachea findings in the females treated at 0.5 mg/L indicate that there was either no direct damage and/or good recovery. There was no indication for systemic toxicity. Based on the outcome of this study, the LC50 for both males and females for the 34.5% aqueous solution of the test substance, is 1-5 mg/L. The 34.5% aqueous solution of the test substance meets therefore the criteria to be classified for acute inhalation toxicity Cat. 4, H332 according to Regulation (EC) No 1272/2008.
The substance is not produced or marketed in neat form. It is only produced and marketed as aqueous formulations at concentrations of approx. 35% and below. Therefore, the second study performed with a 34.5% aqueous formulation of Sodium N-lauroylsarcosinate (CAS 137-16-6), which is the highest technically attainable concentration during the manufacturing process, more closely reflects the potential for acute inhalation toxicity under realistic conditions and at concentrations relevant for human exposure. The data obtained from this study is used to determine specific concentration limits and to derive a classification for the marketed product.
According to Regulation (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2, in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information mentioned in section 8.5.2, acute inhalation toxicity study is provided. Furthermore, testing by the dermal route is not deemed appropriate as the physicochemical properties of the registered substance suggest a low rate of absorption through the skin.
The available data on acute oral toxicity of Sodium N-lauroylsarcosinate (CAS 137-16-6) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.
The available data on the acute inhalation toxicity of Sodium N-lauroylsarcosinate (CAS 137-16-6) meet the criteria for classification for Acute toxicity - inhalation category 4 (H332) according to Regulation (EC) No 1272/2008 at concentrations up to 34.5%. Furthermore, at concentrations > 34.5% the test item meets the criteria for classification for acute inhalation toxicity Cat. 2, H330 according to Regulation (EC) No 1272/2008. Therefore, Sodium N-lauroylsarcosinate (CAS 137-16-6) is classified accordingly.
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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