Registration Dossier

Administrative data

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:
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 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
Body weight:
Not influenced
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

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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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
no clinical signs of intoxication obeserved
Body weight:
not influenced
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.