Registration Dossier
Registration Dossier
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EC number: 809-920-4 | CAS number: 1047637-37-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 November - 13 December 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- EC Number:
- 253-760-2
- EC Name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- Cas Number:
- 38051-10-4
- Molecular formula:
- C13H24Cl6O8P2
- IUPAC Name:
- 2,2-bis(chloromethyl)propane-1,3-diyl tetrakis(2-chloroethyl) bis(phosphate)
- Details on test material:
- Product name: Amgard V6
Appearance: very pale straw coloured viscous liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd, UK
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 161 - 169g males, 143 - 166g females
- Fasting period before study: overnight fast immediately before dosing, and 2 hours after dosing
- Housing: groups of 5 by sex in polypropylene cages
- Diet: ad libitum (Rat and Mouse Expanded Diet No.1)
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 40 - 59
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- - Range finding study: 2000 mg/kg
- Main study: 2000 mg/kg - No. of animals per sex per dose:
- - 1 male, 1 female
- 5 males, 5 females - Control animals:
- no
- Details on study design:
- - Frequency of observations: 0.5, 1, 2, 4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological examination.
Results and discussion
- Preliminary study:
- - Male: found dead one day after dosing; no clinical signs of toxicity 0.5, 1 and 2 hours after dosing; hunched posture and laboured respiration 4 hours after dosing
- Female: no clinical signs of toxicity at 0.5, 1 and 2 hours after dosing; hunched posture and laboured respiration 4 hours after dosing; hunched posture 2 days after dosing; appeared normal 3 to 5 days after dosing
Effect levels
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- 1 male and 1 female were found dead 1 day after dosing
- Clinical signs:
- other: no clinical signs of toxicity noted during the main study
- Gross pathology:
- - Animals found dead 1 day after dosing: haemorrhagic lungs, patchy pallor of liver, dark kidneys
- Animals killed at end of study: no abnormalities noted
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
In an acute oral toxicity study conducted according to OECD Guideline No.401, groups of fasted male and female Sprague-Dawley rats were given a single oral dose of 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) in arachis oil at a dose of 2000 mg/kg bw and observed for 14 days. 2 animals (1 male and 1 female) were found dead 1 day after dosing. No clinicals signs of toxicity have been observed in any of the tested animals.
Oral LD50 Males > 2000 mg/kg bw
Oral LD50 Females > 2000 mg/kg bw
(limit test)
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