Registration Dossier
Registration Dossier
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EC number: 278-855-6 | CAS number: 78169-20-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable study report, well documented, suitable for assessement
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- 10 rats per sex and dose were treated simultaneously with different doses of the test item by gavage. The animals were observed for 14 days for clinical signs. Gross pathology was performed for all of the treated animals.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts)
- EC Number:
- 278-855-6
- EC Name:
- Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts)
- Cas Number:
- 78169-20-7
- Molecular formula:
- unspecified
- IUPAC Name:
- Reaction product of dodecene-1 with mercaptoethanol, ethyleneoxide and sulfuric acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight: males ca. 216 g, females ca. 156 g
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- The test concentration used was 10% (10% aqueous emulsion with CMC).
- Doses:
- 640, 800, 1000, 1250, 1600, 2000, 2500, 3200 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- The LD50 was calculated using the method of LITCHFIELD-WILCOXON.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 950 mg/kg bw
- Mortality:
- 640 mg/kg: 2/20 after 14 days; 800 mg/kg: 4/20 after 14 days; 1000 mg/kg: 13/20 after 14 days; 1250 mg/kg: 16/20 after 14 days; 1600, 2000, 2500, 3200 mg/kg: 20/20 after 14 days
- Clinical signs:
- other: 2600, 2000, 2500 and 3200 mg/kg: dyspnea, slight trembling spasms, apathy, diarrhea, secretion out of the oral cavity, red-agglutinated eyes and noses. 640, 800, 1000 and 1250 mg/kg: dyspnea, scretion out ofthe oral cavity; surviving animals after 6 days
- Gross pathology:
- Animals that died: intestine atony, diarrhea, general venous congestion.
Sacrificed animals: inner organs macroscopically without pathological findings.
Any other information on results incl. tables
Dose (mg/kg bw) |
Conc. (%) |
Treated animals |
Mortality after |
||||
1 h |
24 h |
48 h |
7 days |
14 days |
|||
3200 |
10 |
10 males, 10 females |
8/10 3/10 |
10/10 6/10 |
10/10 10/10 |
10/10 10/10 |
10/10 10/10 |
2500 |
10 |
10 males, 10 females |
0/10 0/10 |
7/10 3/10 |
10/10 9/10 |
10/10 10/10 |
10/10 10/10 |
2000 |
10 |
10 males, 10 females |
0/10 0/10 |
3/10 0/10 |
5/10 4/10 |
10/10 10/10 |
10/10 10/10 |
1600 |
10 |
10 males, 10 females |
0/10 0/10 |
0/10 0/10 |
5/10 0/10 |
10/10 10/10 |
10/10 10/10 |
1250 |
10 |
10 males, 10 females |
0/10 0/10 |
0/10 0/10 |
0/10 0/10 |
9/10 7/10 |
9/10 7/10 |
1000 |
10 |
10 males, 10 females |
0/10 0/10 |
0/10 0/10 |
0/10 0/10 |
6/10 7/10 |
6/10 7/10 |
800 |
10 |
10 males, 10 females |
0/10 0/10 |
0/10 0/10 |
0/10 0/10 |
0/10 3/10 |
0/10 3/10 |
640 |
10 |
10 males, 10 females |
0/10 0/10 |
0/10 0/10 |
0/10 0/10 |
1/10 1/10 |
1/10 1/10 |
The LD50 was calculated using the method of LITCHFIELD-WILCOXON: LD50 = 950 (851 - 1062) mg/kg bw.
Applicant's summary and conclusion
- Executive summary:
The LD50 was calculated using the method of LITCHFIELD-WILCOXON: LD50 = 950 (851 - 1062) mg/kg bw.
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