Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
1994
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

Constituent 1
Chemical structure
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

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)