Registration Dossier
Registration Dossier
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EC number: 500-057-6 | CAS number: 27104-30-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 June 2006 - 18 July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- Storage of the vehicle at room temperature instead of refrigerator. No effect presumed on outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea
- EC Number:
- 500-057-6
- EC Name:
- Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea
- Cas Number:
- 27104-30-9
- Molecular formula:
- C5H16ClN2O5P
- IUPAC Name:
- Phosphonium, tetrakis(hydroxymethyl)-, chloride (1:1), polymer with urea
- Details on test material:
- technical product
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Young healthy adult rats, 8-12 weeks old, body weight at start: 172-194 g, acclimatisation period: 13-15 days.
Husbandry: group caging (4 animals per cage), 12 h light / 12 hours dark; 19-25°C, 30-70% relative humidity.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- single dose
- Doses:
- Sighting study 1: 2000 mg/kg bw (single female rat)
Sighting study 2: 300 mg/kg bw (single female rat)
Main study: 300 mg/kg bw (four female rats)
- No. of animals per sex per dose:
- Sighting study 1: 1 female rat, one dose
Sighting study 2: 1 female rat, one dose
Main study: 4 female rats, one dose
- Control animals:
- no
- Statistics:
- not necessary
Results and discussion
- Preliminary study:
- Sighting study 1 with one female rat, dosage 2000 mg/kg bw: animal found dead after 1 day.
Sighting study 2 with one female rat, dosage 300 mg/kg bw: no evident toxicity and no moratlity.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Sighting study 1: 1/1
Sighting study 2: 0/1
Main study: 0/4 - Clinical signs:
- other: Sighting study 1: decreased activity, tremor, incoordination, hunched back, decreased righting reflex, narrow eye aperture, paleness, piloerection, dyspnoea. lachrymation. First symptoms appeared 2 h after treatment. Sighting study 2, main study: no visib
- Gross pathology:
- No macroscopic changes in all animals.
Sighting study 1: Reddish mottled lungs as indication of an acute circulatory insufficiency during death of the animal.
Sighting study 2 and main study: Pinprick-sized haemorrhages in the lungs (sighting study: 1/1, main study: 2/4)m, hydrometra in the uterus (main study: 2/4).
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- 2000 mg/kg bw of the test item caused mortality in female Wistar rat (1/1) after single oral administration.
300 mg/kg of the test item caused no adverse effect and no mortality in female Wistar rat (0/5) after single oral administration.
The test item was ranked into GHS class 4 and into EPA category III ("Caution") and is considered harmful if swallowed according to EU Commission Directive 2001/59/EC (R22). - Executive summary:
An acute oral toxicity test (fixed dose method) according to OECD 420 was performed on the test item.
At 2000 mg/kg bw, one female rat was dead within 1 day after one single oral adiminstration. At 300 mg/kg bw, all five female rats tested survived the whole observation period of 14 days. The acute oral toxicity of the test item against female Wistar rats was estabhlished between 300 and 2000 mg/kg bw.
The test item was rankec into the GHS class 4 and into the EPA Category III ("Caution").
The test item was considered harmful if swallowed (R22) according to EU Commission Directive 2001/59/EC.
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