Registration Dossier

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:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP for which original study report is available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DCP 208 Proprietary polyalkylene glycol formulation.
- Physical state: brown liquid
- Lot/batch No.: BPDCP208/HRC/June 93
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals were identified with unique number within the study by indelible ink marking on the tail and a number written on a cage card.

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 5-8 weeks old.
- Weight at study initiation: 150-170g males; 135-156g females
- Housing: Animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Fasting period before study: Over night fast immediately before dosing and for approximately two hours after dosing.
- Diet: Ad libitum Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) except during fasting periods.
- Water: Ad libitum except during fasting periods.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-23°C
On two occasions the temperature was below the limit specified in the protocol (19°C). This was not considered to have affected the purpose or integrity of the study.
- Humidity: 41-59%
- Air changes: 15 changes/hr
- Photoperiod: 12 hour light/12 hour dark cycle

IN-LIFE DATES: From: 26 July 1993 To: 18 August 1993

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg/bw

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Doses:
Single Dose 2000mg/kg/bw
No. of animals per sex per dose:
5 males and 5 females.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes, animals were sacrificed by cervical dislocation and subjected to gross pathological examination.
- Other examinations performed: External examination and opening of the abdominal and thoracic cavities were included. Macroscopic abnormalities were recorded. No tissues were retained.
Statistics:
No further details available.

Results and discussion

Preliminary study:
The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days. Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed. There were no deaths. Clinical signs of toxicity noted were ataxia, hunched posture, lethargy, ptosis, loss of righting reflex, laboured and decreased respiratory rate. Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One female was found dead one day after treatment. No other deaths occurred.
Clinical signs:
Common signs of toxicity noted during the day of dosing were hunched posture, lethargy, laboured and decreased respiratory rate, ataxia, loss of righting reflex and ptosis. Two animals were found comatose. All surviving animals appeared normal one day after dosing.
Body weight:
Surviving animals showed expected gain in bodyweight during the study.
Gross pathology:
No further details available.

Any other information on results incl. tables

One animal was found cannibalised and a necropsy was therefore not performed.  No abnormalities were noted at necropsy of animals killed at the end of the study.

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, Poly(oxy-1,2,-ethanediyl), α-butyl, ω-hydroxyl, in the Sprague-Dawley strain rat was found to be greater than 2000mg/kg/bw. No symbol and risk phrase are required according to EEC labelling regulations.
Executive summary:

In a guideline (OECD 401) and GLP study, the acute oral LD50 of a substance meeting the description Poly(oxy-1,2,-ethanediyl), α-butyl, ω-hydroxyl in rats was determined to be greater than 2000 mg/kg/bw.