Registration Dossier

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:
other: This GLP-compliant study was conducted according to a protocol equivalent to OECD guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Di-iodo perfluoro hexane
- Physical state: pink crystalline solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Healthy outbred albino rats derived from the Srague-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 26-MAY-1994 to 10-JUN-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:
Limit test, no statistics needed.

Results and discussion

Effect levels
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:
Piloerection and production of mucoid faeces were observed in female animals on the day of dosing. Piloerection and staining of the skin or fur was noted in animals of both sexes after this time. Staining was observed in the uro-genital region, nose, muzzle and dorsum. Hair loss from various regions of the body was observed during the study.
Body weight:
The body weight gain expected for this strain and age of animal was reduced.
Gross pathology:
No significant abnormalities were found at necropsy, findings being limited to the hair loss noted in-life. In addition, one female animal exhibited a distended uterus.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 a hunched posture, mucoid faeces, skin/fur staining, hair loss and piloerection. Body weight gain was reduced. No significant abnormalities were found at necropsy.

 

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 according to the classification criteria of Regulation (EC) No 1272/2008 (i.e. CLP/EU GHS).