Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate

Endpoint summary

Description of key information

With regard to the endpoint acute systemic toxicity, test data for the oral route on the read-across analogue source substance SMCT is available. Based on an OECD 401 acute oral toxicity study, the limit dose of 2000 mg/kg body weight revealed no mortality and no clinical signs of intoxication. Macroscopic findings during gross pathology were not observed. Based on the findings the LD 50 was established to be greater than 2000 mg/kg body weight. Hence, based on read-across, the acute oral toxicity of the registered/target substance SMLT is considered to be greater 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across study

Justification for type of information:

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. See section 13 for the full read-across justification.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, SPF breeding, Hoe:WISK(SPF71)
- Age at study initiation: 6 -7 weeks
- Weight at study initiation: 187 g +/- 7 g males, 180 g +/- 3 g females
- Fasting period before study: over night
- Housing: Macrolon cages (type 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 hours

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: recommended

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

2000 mg/kg (limit dose)

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no lethality

Clinical signs:

yes (squatting posture, coat bristling)

Body weight:

not influenced

Gross pathology:

no findings

Interpretation of results:

GHS criteria not met

Remarks:

Practically non-toxic via the oral route

Conclusions:

Based on the study results, sodium methyl cocoyl taurate (SMCT) is practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat. Refer to section 13 for read-across justification.

Executive summary:

The acute oral toxicity of sodium methyl cocoyl taurate (SMCT) was tested in 5 male and 5 female Sprague Dawley rats at a dose level of 2000 mg/kg body weight (limit test) according to OECD Guideline 401. The animals received the compound once as a 20% suspension in water as vehicle via gavage and the administration volume was 10 mL/kg body weight. The observation period following treatment lasted 14 days. Unspecific symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 30 minutes up to 4 - 6 hours post application. No mortality occurred. From day 1 until the end of the observation period no symptoms of toxicity were observed. The development of body weight was not impaired. None of the animals showed macroscopically visible changes. Based on the study results, the median lethal dose (LD50) of SMCT is greater than 2000 mg/kg body weight in rats.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat. Refer to section 13 for read-across justification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The read-across source substance SMCT is parctically non toxic following acute oral administration up to the limit dose of 2000 mg/kg body weight. Data are reliable and meet criteria for classification & labeling requirements.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The acute oral toxicity of the read-across source substance SMCT was investigated in 5 male and 5 female rats using purified water as vehicle. The study was performed according to OECD test guideline 401 and followed the principles of GLP. 5male and 5 female animals were administered the test compound by single-dose gavage at a dose-level of 2000 mg/kg body weight. The observation period was 14 days. No deaths occurred during the study. Beside unspecific findings shortly after administration, clinical signs of intoxication were also not observed during the course of the study. Body weight development was normal and within the range commonly recorded for this strain and age. At necropsy no macroscopic findings were recorded. Based on the findings of this limit-test the median lethal dosage (LD50) of the source substance in female rats is greater than 2000 mg/kg body weight.

From the available data, based on read-across it is concluded that the registration/target substance SMLT is practically non-toxic following oral and/or dermal administration.

Justification for selection of acute toxicity – oral endpoint
Guideline read-across study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.

Justification for selection of acute toxicity – inhalation endpoint
Waiving for scientific and exposure based reasons. Acute systemic toxicity can be excluded for the oral and/or dermal route of exposure. Additionally, due to the physico-chemical characteristics, no significant potential concerning inhalation exposure exist. Additionally, due to cosmetic use, vertebrate testing on SMLT is prohibited according to Regulation (EC) 1223/2009.

Justification for classification or non-classification

With regard to the endpoint acute systemic toxicity, test data for the oral route on the read-across analogue source substance SMCT is available. Based on an OECD 423 acute oral toxicity study, the limit dose of 2000 mg/kg body weight revealed no mortality and no clinical signs of intoxication. Macroscopic findings during gross pathology were not observed. Based on the findings the LD 50 was established to be greater than 2000 mg/kg body weight. Hence, based on read-across, the acute oral toxicity of the registered/target substance SMLT is considered to be greater 2000 mg/kg body weight.

From the available read-across data, it is concluded that the registration/target substance SMLT is pactically non-toxic following oral and/or dermal administration and not classified for acute toxicity.