Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
EC Number:
939-538-4
Molecular formula:
not applicable
IUPAC Name:
sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
CAS name: Sodium methyl cocoyl taurate
Name: Ölsäuremethyltaurid-Natriumsalz
CAS: 91673-22-2

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.