Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 >5000 mg/kg bw

RA from source substance (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8)

Inhalation (OECD 403), rat: LC50 = 1.37 mg/L air

RA from source substance (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8)

Dermal (OECD 402), rat, LD50 > 2000 mg/kg bw

RA from souce substances N-lauroylsarcosine (CAS 97-78-9), Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) and Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2) from an analogue substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

1 370 mg/m³ air

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2) from an analogue substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises 3 adequate and reliable studies (all Klimisch score 1) from relevant source substances with similar structures and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

No data on acute toxicity are available for the target substance Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 76622-74-7). Therefore, oral and inhalation acute toxicity was read-across from the source substance (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8). Read-across source substances N-lauroylsarcosine (CAS 97-78-9), Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) and Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) have been used to derive appropriate data for the acute dermal toxicity of Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 76622-74-7).

Acute toxicity: oral

An acute oral toxicity study performed equivalent or similar to OECD TG 401 with (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8) is available (Ciba Geigy, 1981a). In this limit test five fasted Sprague-Dawley rats of each sex were administered a single dose of 5000 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days after administration. No mortality occurred during the study period and body weight gain was normal. Observed clinical signs included slight dyspnoea, slight exophthalmos and slight to moderate ruffled fur and slight to moderate diarrhoea as well as a slightly curved body position. All these clinical signs were fully reversible in all animals within 7 days. No substance-related findings were recorded at necropsy. Thus, the acute oral LD50 value was considered to be greater than 5000 mg/kg bw. Based on the study results and according to EU classification criteria, the target substance Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 76622-74-7) does not need to be classified.

 

Acute toxicity: inhalation

A reliable acute inhalation toxicity study was performed with (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8) equivalent or similar to OECD TG 403 (BASF, 1979). Groups of 10 Sprague-Dawley rats of each sex were exposed via nose / head only to 0.3, 0.6, 2.2 and 3.7 mg test substance/L air for 4 h. The substance was tested as an inhalable aerosol (no further information on MMAD available). The animals were observed for a period of 14 days following administration. Mortality of male and female rats was recorded in the 0.6, 2.2 and 3.7 mg/L air dose groups (3/10, 10/10 and 8/10 for males and 1/10, 4/10 and 10/10 for females, respectively). Clinical signs of toxicity were observed in all surviving animals including flight attempts, gasping and noisy breathing, slight staggering, bloody nose area, low motility, hair loss in the head area and salivation in varying degrees. Surviving animals were free of symptoms from Day 2 - 8 after treatment and necropsy revealed no abnormalities. Body weight loss was observed in females of the 2.2 mg/L and in males of the 3.7 mg/L dose groups. In animals that died during the study period, clinical signs of toxicity such as acute dilatation, acute hyperemia, edema and hyperemia of the lungs, severe exhalation especially at the peripheral areas, severe edema formation and laminar bleedings of the lungs (high-dose group) were observed. Thus, the acute inhalation LC50 value is calculated to be 1.8 and 1.05 mg/l air for females and males, respectively, whereas the combined acute inhalation LC50 value is considered to be 1.37 mg/l air after 4 h exposure to the test material. Based on the study results, the source substance meets the criteria for classification for Acute Tox. 4 (H332) according to Regulation (EC) No 1272/2008.

Acute toxicity: dermal

A reliable acute dermal toxicity study has been performed using N-lauroylsarcosine (CAS 97-78-9) in accordance with OECD guideline 402 under GLP conditions (Phycher, 2014). A group of 10 Sprague Dawley rats (5 males and 5 females) was treated with the unchanged test substance at the limit dose of 2000 mg/kg bw under semi-occlusive conditions for 24 h. After the treatment period the application site was rinsed, and the animals were observed for a period of 14 days following administration. No mortality occurred in the study. During the observation period no clinical signs of toxicity or effects on body weight were observed in any animal, and no treatment-related pathological changes were found during necropsy. Only local cutaneous reactions (erythema, dryness, scab) were observed at the application site in all animals from Day1 which remained until Day 14 (scab) in all females and in one male. In conclusion, the dermal LD50 was considered to be greater than the tested limit dose of 2000 mg/kg bw.

In another reliable acute dermal toxicity study, Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) was tested according to OECD guideline 402 under GLP conditions (Harlan, 2013a). Groups of 10 rats (5 males and 5 females) were treated with the test substance moistened with arachis oil BP at the limit dose of 2000 mg/kg bw under semi-occlusive conditions for 24 h. The animals were observed for a period of 14 days following administration. During the study period, no mortality and no clinical signs of toxicity occurred in any animal. No substance-related findings during necropsy were observed in any animal. No effects on body weight gain were observed with the exception of one female which showed bodyweight loss during the first week but expected weight gain during the second week. Evaluation of the dermal skin reactions showed very slight erythema (Draize scoring value: 1) at the test sites of 7/10 animals being fully reversible within at the most 5 days. No edema formation was observed in any animal. Crust formation was noted at the test site of one female being reversible within 9 days. Therefore, the dermal LD50 was considered to be greater then 2000 mg/kg bw.

An acute dermal toxicity study performed according to OECD TG 402 and complying to GLP provisions with Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) is available (Frey-Tox, 2016). In this limit test five Wistar rats of each sex were exposed to a single dose of 2000 mg/kg bw of the neat test substance for 24 h via semi-occlusive dressing and observed for 14 days post-application. No mortalities occurred and no systemic clinical signs of toxicity related to the administration of the test item were observed up to the end of the 14-day observation period. Furthermore, no effect on body weight development was recorded during the study period. Macroscopic examination at the end of the study revealed no treatment-related changes. On day 1, very slight erythema formation (grade 1) was observed in 2/10 animals, whereas slight to well defined erythema (grade 2) were observed in 7/10 animals. Additionally, very slight edema formation (grade 1) was observed in 2/10 animals. On day 2, very slight erythema (grade 1) were observed in 5/10 animals and slight to well defined erythema (grade 2) were recorded in 4/10 animals. Very slight erythema (grade 1) were also observed in 3/10 animals on day 3 after test material application. Furthermore, the treated skin areas of 6/10 animals displayed isolated scales (day 3). However, all skin reactions were fully reversible within 4 days after application of the test material until the end of the study period. Thus, the acute dermal LD50 value was considered to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

The available data on relevant read-across source substances for both acute oral and acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008. Therefore, applying the RA-A approach, the target substance Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 76622-74-7) is also considered not to meet the criteria for classification for acute oral and dermal toxicity according to Regulation (EC) No 1272/2008. Data therefore are conclusive but not sufficient for classification.

The available data on a relevant read-across source substance for acute inhalation toxicity meet the criteria for classification for acute inhalation toxicity, category 4, aerosol (H332) according to Regulation (EC) No. 1272/2008. Therefore, applying the RA-A approach, the target substance Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 76622-74-7) is also considered to meet the criteria for classification for acute inhalation toxicity, category 4 (H332) according to Regulation (EC) No 1272/2008.