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Toxicological information

Acute Toxicity: dermal

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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:
1991
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

Constituent 1
Chemical structure
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

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:
No clinical signs of intoxication observed
Body weight:
Not influenced
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.