Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 September 2012 to 18 October 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: RccHan:WIST
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: The animal dosed first weighed 160 g. The bodyweight variation did not exceed ± 20 % of the initially dosed animal.
- Fasting period before study: Yes. The animals were fasted overnight prior to dosing and for approximately 3 to 4 hours post-dosing.
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum access to mains drinking water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give twelve hours continuous light (0600 to 1800) and twelve hours darkness.

IN-LIFE DATES: From: 20 September 2012 To: 18 October 2012

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: The test material did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 female animals per dose
Control animals:
no
Details on study design:
Following a sighting test with a single animal being treated at a dose level of 2000 mg/kg bodyweight, an additional four fasted animals were dosed at the same level.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on day 0 (the day of dosing) and on days 7 and 14.
- Necropsy of survivors performed: Yes; all animals were subjected to gross necropsy. Animals were killed by cervical dislocation. An external examination was performed and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Results and discussion

Preliminary study:
There was no mortality in the sighting test and no clinical observations noted.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were observed.
Body weight:
All animals showed the expected gains in bodyweight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 >2000 mg/kg bodyweight
Executive summary:

The acute oral toxicity potential of the test material in female Wistar strain rats was assessed in accordance with the standardised guidelines OECD 420 and EU Method B.1 bis under GLP conditions.

Following a sighting test in a single animal at a dose level of 2000 mg/kg, the test material was administered by gavage as a solution in arachis oil BP at the same dose level to an additional four animals. The animals were observed for 14 days.

There was no mortality and no clinical signs were observed. All animals showed the expected gains in bodyweight throughout the observation period.

Under the conditions of this study, the acute oral LD50 was >2000 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.