Registration Dossier
Registration Dossier
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EC number: 263-174-9 | CAS number: 61791-42-2
Acute Toxicity: dermal
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Sodium 2-[methyloleoylamino]ethane-1-sulphonate
- EC Number:
- 205-285-7
- EC Name:
- Sodium 2-[methyloleoylamino]ethane-1-sulphonate
- Cas Number:
- 137-20-2
- Molecular formula:
- C21H41NO4S.Na
- IUPAC Name:
- sodium 2-[methyl(oleoyl)amino]ethanesulfonate
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- paste
- Details on test material:
- CAS name: Sodium methyl oleyl taurate
Name: Ölsäuremethyltaurid-Natriumsalz
Constituent 1
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: 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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