Registration Dossier
Registration Dossier
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EC number: 203-614-9 | CAS number: 108-77-0
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: Guideline study with acceptable restrictions (e.g. non GLP study, report finalized 5 years after study conduction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- as at 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- as at 1984,
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,4,6-trichloro-1,3,5-triazine
- EC Number:
- 203-614-9
- EC Name:
- 2,4,6-trichloro-1,3,5-triazine
- Cas Number:
- 108-77-0
- Molecular formula:
- C3Cl3N3
- IUPAC Name:
- trichloro-1,3,5-triazine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in house breeding colony
- Age at study initiation: 6-10 (males) and 8-10 weeks (females)
- Weight at study initiation: 215-400 g (males) and 190 - 250 g (females)
- Fasting period before study: 16 h
- Housing: stainless steel cages with grating floor, 1 animal per cage
- Diet: standard diet ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 22.5
- Humidity (%): 50 -65
- Photoperiod (hrs dark / hrs light): 6 a.m - 6 p.m. artificial lighting, 6 p.m.- 6 a.m. natural light dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 % (w/v)
- Amount of vehicle: 2.4, 3.0, 3.25, 3.75, 4.70 ml/kg bw
MAXIMUM DOSE VOLUME APPLIED: 470 mg/kg bw - Doses:
- - 240, 300, 325, 375, 470 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: first 4 h after administration, then daily; Weighing: day 0 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy, histopathology of stomach and liver - Statistics:
- - probit analysis
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 315 mg/kg bw
- 95% CL:
- 303 - 357
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 356 mg/kg bw
- 95% CL:
- 317 - 426
- Remarks on result:
- other: error in calculation (report)
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 327 mg/kg bw
- Remarks on result:
- other: as recalculated by reviewer of the SIDS dossier on CAS 108-77-0
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 333.6 mg/kg bw
- 95% CL:
- 293.4 - 373.8
- Remarks on result:
- other: recalculated by the reviewer using the probit analysis using AnalystSoft, BioStat, statistische Analyse. Version 2008. (http://www.analystsoft.com/de/products/biostat/)
- Mortality:
- Mortality was observed between 24h post application and day 2
males: 240 mg/kg bw 0/5
300 mg/kg bw 0/5
325 mg/kg bw 4/5
375 mg/kg bw 5/5
470 mg/kg bw 5/5
females: 240 mg/kg bw 0/5
300 mg/kg bw 0/5
325 mg/kg bw 3/5
375 mg/kg bw 2/5
470 mg/kg bw 5/5 - Clinical signs:
- other: - hypokinesia, somnolency, decreased muscle tone, loss of righting reflex, loss of pain reflex, loss of corneal reflex, piloerection, accelerated respiration and decreased body temperature
- Gross pathology:
- - Macroscopic findings noted at necropsy included: stomach lesions such as reddening, inflation,
reddened gastric mucous membrane, thickened fundus, fusion with peritoneum/liver/spleen and reddening
of the intestinal mucosa
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this acute oral toxicity study a combined LD50 for both sexes of 333.6 mg/Kg bw (293.4 — 373.8 95% CL) was deduced in rats.
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