Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 > 2000 mg/kg bw

Data from registered substance and read-across from structural source substance sodium 2-[methyloleoylamino]ethane-1-sulphonate(CAS 137-20-2).

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

Read-across from structural source substance sodium 2-[methyloleoylamino]ethane-1-sulphonate (CAS 137-20-2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 ± females
- Fasting period before study: over night
- Housing: Macrolon cages (type 4)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approximately 5 days

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

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: recommended

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw (limit dose)

No. of animals per sex per dose:

5

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No lethality

Clinical signs:

other: 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. From day 1 until the end of the observation period no symptoms of toxicity were observed.

Gross pathology:

No findings

Interpretation of results:

other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

Refer to analogue justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source: CAS 137-20-2, Clariant, 1987b

Interpretation of results:

other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

An LD50 value > 2000 mg/kg bw has been determined for male and female rats.

Executive summary:

The acute oral toxicity of the target substance is estimated based on an adequate and reliable in vivo study of a structural analogue source substance. The LD50 value determined is > 2000 mg/kg bw for male and female rats. Therefore, a LD50 value of > 2000 mg/kg bw for the target substance is considered for the hazard assessment and C&L purposes. As explained in the analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The information from the independent acute oral toxicity studies (Klimisch 1-2) is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No. 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: adult
- Weight at study initiation: 188 ± 4.5 g (male), 167 ± 7.1 (female)
- Fasting period before study: over night
- Housing: Macrolon cages (type 3)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 28 - 40
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10%
- % coverage: 100

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

TEST MATERIAL
- Amount applied: 2000 mg/kg bw (limit dose)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw (limit dose)

No. of animals per sex per dose:

5

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No lethality occurred

Clinical signs:

other: No clinical signs of intoxication observed

Gross pathology:

No specific compound-associated pathology was found, except some residual discoloration of the skin at the application site.

Interpretation of results:

other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No. 1907/2006.

Additional information

Acute oral toxicity

Data requirement on acute oral dose toxicity of Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts is covered in a weight of evidence approach with data on Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts

and the source substance Sodium 2 -[methyloleoylamino]ethane-1 -sulphonate. Both, the target and the source substance are chemically reaction products of fatty acid chlorides with Sodium N-methyl taurinate. The only difference between both substances is seen in the origin of the fatty acid, which represents a C12 -18(even numbered, C18 unsaturated)-alkyl chain in the target and a C18 -(unsaturated)-alkyl chain in the source molecule. The molecular structure of both materials is characterized by the hydrophobic aliphatic alkyl chain with N-methyl taurine as hydrophilic head group, giving the whole molecule amphiphilic properties.

The acute oral toxicity of Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts 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 under GLP conditions (Clariant, 1987a). The animals received the compound once as a 20% suspension in water via gavage and the administration volume was 10 mL/kg body weight. The observation period following treatment lasted 14 days. No mortality occurred. Unspecific clinical symptoms like hypoactivity, squatting posture and coat bristling were observed in all animals from 10 - 30 minutes up to 4 - 6 hours post application. From day 1 until the end of the observation period no clinical signs were observed. The development of body weight was not impaired. None of the animals showed macroscopically visible changes at gross pathology. Based on the study results, the LD50 of Sodium methyl cocoyl taurate is greater than 2000 mg/kg body weight in rats.

The acute oral toxicity of the source substance Sodium 2 -[methyloleoylamino]ethane-1 -sulphonate 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 under GLP conditions (Clariant, 1987b). The animals received the compound once as a 20% suspension in water via gavage and the administration volume was 10 mL/kg body weight. The observation period following treatment lasted 14 days. No mortality occurred. Unspecific clinical symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 60 minutes post application. From 1 hour after adminstration onwards no clinical symptoms of toxicity were observed until the end of the observation period. Body weight development was not impaired. None of the animals showed macroscopically visible changes at gross pathology. Based on the study results, the LD50 for Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts is greater than 2000 mg/kg body weight in rats.

Acute dermal toxicity

Data requirement on acute dermal dose toxicity of Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts is covered by a read-across to the source substance Sodium 2 -[methyloleoylamino]ethane-1 -sulphonate.Both, the target and the source substance are chemical reaction products of fatty acid chlorides with Sodium N-methyl taurinate. The only difference between both substances is seen in the origin of the fatty acid, which represents a C12 -18(even numbered, C18 unsaturated)-alkyl chain in the target and a C18 -(unsaturated)-alkyl chain in the source molecule. The molecular structure of both materials is characterized by the hydrophobic aliphatic alkyl chain with N-methyl taurine as hydrophilic head group, giving the whole molecule amphiphilic properties.

The source substance Sodium 2 -[methyloleoylamino]ethane-1 -sulphonate was tested for acute dermal toxicity in 5 male and 5 female rats according to OECD guideline 402 following the principles of GLP (Leuna-Tenside, 1991). After administration of a single dermal dose of 2000 mg/kg body weight, no specific test item related findings were observed during the subsequent 14 day observation period. Body weight gain was not adveresly effected througout the study period. At necropsy, no specific compound-associated pathology was found, except some residual discoloration of the skin at the application site. Based on the study results, the acute dermal toxicity (LD 50) of Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts in the rat was determined to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

The available data on acute oral and dermal toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. No data is available on acute inhalation toxicity.