1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03-MAY-1994 to 13-SEP-1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

This GLP-compliant study was conducted according to an EC method equivalent to OECD guideline 401 (Commission Directive 92/69/EEC).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

EC Number:

206-788-4

EC Name:

1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

Cas Number:

375-50-8

Molecular formula:

C4F8I2

IUPAC Name:

1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

Test material form:

other: liquid

Specific details on test material used for the study:

Red liquid, no purity stated.

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 17338/35

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambien conditions, away from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Healthy outbred albino rats derived from the Sprague-Dawley strain (CD(SD)BR)
- Source: Charles River Italia S.p.A., Calco (Como), Italy
- Age at study initiation: 5 to 6 weeks (with female animals nulliparous and non-pregnant)
- Weight at study initiation: 126 to 150 g
- Fasting period before study: overnight fast prior to dosing (and a period of approximately 4 hrs following dosing)
- Housing: in group of 5 of one sex, in polycarbonate cages measuring 59x39x20 cm and equipped with a stainless steel mesh lid and floor; each cage was identified by a colour coded label recording the study number, animal number and the details of treatment.
- Diet: ad libitum, via a commercially available laboratory rodent diet (Altromin MT, A. Riper S.p.A., Bolzano, Italy)
- Water: ad libitum, via water bottle
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 to 70%
- Air changes: no data available
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 05-MAY-1994 to 26-MAY-1994

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Alembicol D (fractionated coconut oil)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle, lot/batch no., purity: no data available

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: throughout the study, mortality was checked at the start of each working day and again in the afternoon to look for dead or moribund animals. However, at weekends the final check was carried out at approximately mid-day to allow for necessary necropsy examinations to be made the same day. In addition, all animals were weighed the day before dosing, at allocation to the study, immediately prior to dosing (day 1) and at weekly intervals (days 8 and 15).
- Necropsy of survivors performed: yes; all animals were killed on day 15 by carbon dioxide narcosis.
- Other examinations performed: clinical signs (immediately upon dosing, approximately 1, 2 and 4 hrs after dosing and daily thereafter for a total of 14 days)

Statistics:

When a formal assessment of the LD50 was undertaken, the mortality data generated was subjected to analysis. Suitable statistical methods were used to provide an estimate of the median lethal dose and slope of the dose-response curve with, where possible, confidence limits to the estimation.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the 14-day observation period following dosing.

Clinical signs:

Reduced activity, a hunched posture and production of mucoid faeces were observed in all animals (5M, 5F) on the day of dosing, 4 hours after administration. At 24 hours post-dosing, ataxia was noted in 2 males and 2 females, and a hunched posture in 2 females. In females, hair loss from the dorsal surfaces (day 3 to 15), skin/fur staining (day 3 to 11), and piloerection in males and females (day 9 to 13) were apparent during the remaining post-dose observation period.

Body weight:

Changes in body weight observed during the period of the study were within the range expected for this strain and age of animal.

Gross pathology:

No significant abnormalities were found at necropsy, findings being limited to the hair loss in-life.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results of this study indicated that the test substance had no significant toxic effect in male and female albino rats following oral administration of a single dose at a level of 2000 mg/kg.

Executive summary:

The acute oral toxicity of the test substance was investigated in the albino rat according to a protocol equivalent to OECD guideline 401 and in compliance with good laboratory practices (GLP).

 

A single dose of 2000 mg/kg (in Alembicol) was orally administered by gavage to male and female rats (5/group and sex). Animals were observed for a total of 14 days post-dose. Rats were then killed and subjected to necropsy examination.

 

No mortality occurred. Clinical signs observed after dosing included ataxia, a hunched posture, reduced activity, mucoid faeces, skin/fur staining, hair loss and piloerection. Changes in body weight were unremarkable. Necropsy revealed no significant abnormalities.

 

As a consequence, the oral LD50 of the test substance in rats was higher than 2000 mg/kg, therefore warranting no classification for this substance.