Registration Dossier
Registration Dossier
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EC number: 225-208-0 | CAS number: 4719-04-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol
- EC Number:
- 225-208-0
- EC Name:
- 2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol
- Cas Number:
- 4719-04-4
- Molecular formula:
- C9H21N3O3
- IUPAC Name:
- 2,2',2''-(1,3,5-triazinane-1,3,5-triyl)triethanol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PK 95/222
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refridgerated
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Weight at study initiation: 150-300 g
- Fasting period before study: 16 h
- Housing: Single housing in fully air-conditioned rooms.
- Diet: ad libitum, Kliba-Labordiaet (Klingentakmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: for at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The animals were treated by single gavage after having been fasted for 16 hours.
- Doses:
- 500, 1000 and 2000 mg/kg bw
- 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: Several times on the day of administration, at least once each workday for the individual animal.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology. - Statistics:
- LD50 values for male and female rats were calculated with the probit model (Finney, 1971).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 4 male and all female animals of the 2000 mg/kg bw dose group, 2 male and 4 female rats of the 1000 mg/kg bw dose group died within 2 days after application.
- Clinical signs:
- other: Signs of toxicity noted in the 2000, 1000 and 500 mg/kg bw dose groups comprised impaired or poor general state, dyspnoea, apathy, abdominal or lateral position, staggering, ataxia, atonia, paresis, themor, cyanosis and diarrhoea.
- Gross pathology:
- Necropsy findings of the animals that died comprised agonal congestion, erythema, parietal edema and erosion/ulcer in the glandular stomach and discoloration of the mucosa of the forestomach and the glandular stomach.
Histopathological examination of the stomach revealed edema of submucosa in the glandular stomach, margo plicatus and at transition to forestomach, mixed-cell infiltration of submucosa and hyperdemia.
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
Any other information on results incl. tables
Dose (mg/kg bw) |
Mortality (Died/Treated) |
|||||||||||||
1 hour |
2 hours |
3 hours |
4 hours |
1 day |
2 days |
14 days |
||||||||
male |
female |
male |
female |
male |
female |
male |
female |
male |
female |
male |
female |
male |
female |
|
500 |
0/5 |
0/5 |
0/5 |
- |
- |
0/5 |
0/5 |
- |
0/5 |
0/5 |
- |
0/5 |
0/5 |
0/5 |
1000 |
0/5 |
0/5 |
0/5 |
- |
- |
1/5 |
0/5 |
- |
2/5 |
3/5 |
- |
4/5 |
2/5 |
4/5 |
2000 |
1/5 |
2/5 |
2/5 |
- |
- |
2/5 |
3/5 |
- |
4/5 |
5/5 |
- |
- |
4/5 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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