Fatty acid chlorides, C18 unsatd., reaction products with sodium N-methyltaurinate

Endpoint summary

Description of key information

With regard to the acute toxicity of the registered substance, test data for the oral and dermal exposure route are 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. The acute dermal toxicity of the registered substance was evaluated in an OECD 402 study according to GLP. After topical treatment with the limit dose of 2000 mg/kg body weight neither mortality nor significant clinical symptoms of intoxication were observed. The LD50 after dermal treatment was established 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:

other: Guideline study according to GLP

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:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG (Hoe: WISKf(SPF71)
- Age at study initiation: 6-7 weeks (male, 7-8 weeks (female)
- Weight at study initiation:
- Fasting period before study: approximately 16 hours
- 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
- Photoperiod (hrs dark / hrs light): 12 hours

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

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

Doses:

2000 mg/kg body weight (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,

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Gross pathology:

No effects

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was practically non-toxic after oral administration to rats.

Executive summary:

The acute oral toxicity of the registration substance 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 - 60 minutes post application. From 1 hour after adminstration onwards no clinical symptoms of toxicity were observed until the end of the observation period. No mortality occurred. Body weight development was not impaired. None of the animals showed macroscopically visible changes. Based on the study results, the median lethal dose (LD50) of the registration substance is greater than 2000 mg/kg body weight in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The registered substance is parctically non toxic following acute oral administration up to the limit dose of 2000 mg/kg body weight. Data 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:

other:

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:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

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 (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

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

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10%
- % coverage: 100 %
- Type of wrap if used: semi-occlusive

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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight (limit dose)
- Concentration (if solution): undiluted

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight (limit dose)

No. of animals per sex per dose:

5 males, 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

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 obeserved

Gross pathology:

no specific compound-associated pathology

Other findings:

no other findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the study results, sodium methyl oleyl taurate is practically non-toxic after dermal application to rats.

Executive summary:

Sodium methyl oleyl taurate was tested for acute dermal toxicity in male and female rats according to OECD TG 402 following the principles of GLP. 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 with regard to clinical signs of intoxication. Body weight gain was not significantly effecte 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 sodium methyl oleyl taurate in the rat was determined to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The registered substance is parctically non toxic following acute dermal administration up to the limit dose of 2000 mg/kg body weight. Data reliable and meet criteria for classification & labeling requirements.

Additional information

The acute oral toxicity of the registered substance 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 registered substance in female rats is greater than 2000 mg/kg body weight.

The registration substance was tested for acute dermal toxicity in male and female rats according to OECD TG 402 following the principles of GLP. 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 with regard to clinical signs of intoxication. Body weight gain was not significantly effecte 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 sodium methyl oleyl taurate in the rat was determined to be greater than 2000 mg/kg body weight.

From the available data it is concluded that the registration substance is practically non-toxic following oral and/or dermal administration.

Justification for selection of acute toxicity – oral endpoint
Guideline 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.

Justification for selection of acute toxicity – dermal endpoint
Guideline 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 classification or non-classification

Based on the results from available guideline studies which revealed LD50 values greater than 2000 mg/kg body weight, the registration substance is not subject to labelling and classification requirements with regard to the oral or dermal route of exposure.