Registration Dossier
Registration Dossier
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EC number: 203-927-0 | CAS number: 112-00-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 26, 1985 to May 15, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Dodecyltrimethylammonium chloride
- EC Number:
- 203-927-0
- EC Name:
- Dodecyltrimethylammonium chloride
- Cas Number:
- 112-00-5
- Molecular formula:
- C15H34N.Cl
- IUPAC Name:
- N,N,N-trimethyldodecan-1-aminium chloride
- Reference substance name:
- Trimethyl(tetradecyl)ammonium chloride
- EC Number:
- 224-958-6
- EC Name:
- Trimethyl(tetradecyl)ammonium chloride
- Cas Number:
- 4574-04-3
- Molecular formula:
- C17H38N.Cl
- IUPAC Name:
- N,N,N-trimethyltetradecan-1-aminium chloride
- Reference substance name:
- Cetrimonium chloride
- EC Number:
- 203-928-6
- EC Name:
- Cetrimonium chloride
- Cas Number:
- 112-02-7
- Molecular formula:
- C19H42N.Cl
- IUPAC Name:
- N,N,N-trimethylhexadecan-1-aminium chloride
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- CAS 112-00-5
mol. weight structur: 263.9
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Dr. K. Thomae GMBH. D-7950 Biberach. FRG
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Acclimatization period: acclimatization for at least 1 week
Number of animals per dose: 5 male animals / 5 female animals
Type of cage: Stainless steel wire mesh cages.
Number of animals per cage: 5
Room temperature / relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees celsius for temperature and of 30 - 70% for relative humidity.
Day/night rhythm: 12h/12h (6.00 - 18.00 hours/ 18.00 - 6.00 hours)
Drinking water: tap water ad libitum per day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqueous formulation corresponds to the physiological medium
- Details on oral exposure:
- Fasting period: the animals are given no feed 16 hours before administration. But water is available as libitum.
Route of administration: Single oral administration by gavage.
Form of administration: Solution - Doses:
- Doses (mg/kg): 5000, 1000, 681 and 464
- No. of animals per sex per dose:
- Number of animals per dose: 5 male animals / 5 female animals
- Control animals:
- no
- Details on study design:
- Acclimatization period: acclimatization for at least 1 week
Number of animals per dose: 5 male animals / 5 female animals
Doses (mg/kg): 5000; 1000; 681; 464
Type of cage: Stainless steel wire mesh cages.
Number of animals per cage: 5
Room temperature / relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees celsius for temperature and of 30 - 70% for relative humidity.
Day/night rhythm: 12h/12h (6.00 - 18.00 hours/ 18.00 - 6.00 hours)
Drinking water: tap water ad libitum per day
Observation period: 14 D
Signs and symptoms: Recording of signs and symptoms several times on the day of administration. At least once each workday. Check - Statistics:
- Model of dose-response relationship with test for homogeneity (Chi2 test).
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 910 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- 681 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 680 - < 980
- Mortality:
- See Section "Any other information on results incl. tables"
- Clinical signs:
- other: See Section "Any other information on results incl. tables"
Any other information on results incl. tables
Mortality
Male
| Dose (mg/kg) | 5000 | 1000 | 681 | 464 |
| N° of animals | 5 | 5 | 5 | 5 |
| Dead animals after 1H | 5 | 0 | 0 | 0 |
| Dead animals after 1D | 5 | 0 | 0 | 0 |
| Dead animals after 2D | 5 | 0 | 0 | 0 |
| Dead animals after 7D | 5 | 3 | 1 | 0 |
| Dead animals after 14D | 5 | 3 | 1 | 0 |
Female
| Dose (mg/kg) | 5000 | 1000 | 681 | 464 |
| N° of animals | 5 | 5 | 5 | 5 |
| Dead animals after 1H | 5 | 0 | 0 | 0 |
| Dead animals after 1D | 5 | 1 | 0 | 0 |
| Dead animals after 2D | 5 | 1 | 0 | 0 |
| Dead animals after 7D | 5 | 5 | 2 | 0 |
| Dead animals after 14D | 5 | 5 | 2 | 0 |
Clinical signs
Symptoms male animals
| Dose (mg/kg) | 5000 | 1000 | 681 | 464 |
| Dyspnea | 15M-30M | 30M-9D | ||
| Apathy | 15M-30M | 30M-8D | ||
| Staggering | 15M-30M | 1D-8D | 1H-5H | |
| Twitching | 15M-30M | |||
| Piloerection | 1D-8D | |||
| Diarrhea | 4H-5H | |||
| Cyanosis | 15M-30M | |||
| Salivation | 15M-30M | |||
| Poor general state | 15M-30M | 30M-8D |
Symptoms female animals
| Dose (mg/kg) | 5000 | 1000 | 681 | 464 |
| Dyspnea | 15M-30M | 30M-1D | ||
| Apathy | 15M-30M | 30M-1D | ||
| Abnormal position | 30M | |||
| Staggering | 15M | 1D | 1H-5H | |
| Twitching | 15M-30M | |||
| Piloerection | 1D | |||
| Diarrhea | 1H-5H | |||
| Cyanosis | 15M-30M | |||
| Exophthalmos | 15M-30M | |||
| Salivation | 15M-30M | |||
| Poor general state | 15M-30M | 30M-1D |
Body weight (grams)
Male
| Dose (mg/kg) | 5000 | 1000 | 681 | 464 |
| Beginning of the test-mean weight (g) | 220 | 180 | 177 | 180 |
| After 2D | 179 | 205 | ||
| After 7D | 195 | |||
| After 7D | 222 | 239 | ||
| After 13D | 248 | |||
| After 13D | 249 | 263 |
Female
| Dose (mg/kg) | 5000 | 1000 | 681 | 464 |
| Beginning of the test-mean weight (g) | 202 | 179 | 192 | 180 |
| After 2D | 192 | 198 | ||
| After 7D | ||||
| After 7D | 217 | 218 | ||
| After 13D | ||||
| After 13D | 222 | 223 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 after 14D
MALE: EQUALS 910 (MG/KG) SLOPE FACTOR = 1.35
FEMALE: ABOUT 681 (MG/KG)
MALE+FEMALE: EQUALS 800 (MG/KG) SLOPE FACTOR = 1.28 - Executive summary:
Executive summary on the study of acute oral toxicity:
Testing Facility: BASF Aktiengesellschaft
Aim of the study: Estimate of the potential acute hazard after single administration (determination of the LD50)
Test Substance N°: 84/401
Name of test substance: LUVISOFT KTM
Results (LD50 after 14D):
MALE: EQUALS 910 (MG/KG) SLOPE FACTOR = 1.35
FEMALE: ABOUT 681 (MG/KG)
MALE+FEMALE: EQUALS 800 (MG/KG) SLOPE FACTOR = 1.28
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