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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
no clinical signs of toxicity noted during the main study
Body weight:
surviving animals showed expected gain in body weight
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)