Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
% Total Organic Solids: 25.27%

Test animals

Species:
rat
Strain:
other: HanTac:WH (Wistar Hannover GALAS)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconic Europe A/S, DK-4623 Lille Skensved, Denmark
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 149 - 160 g
- Fasting period before study: overnight
- Housing: The animals were kept in transparent polycarbonate cages (floor area: 1500 cm² Height 21cm) with two in each cage. The cages were cleaned and the bedding changed at least twice a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ±3°C
- Humidity (%): 55% ±15%.
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): cycle of 12 hours light and 12 hours darkness

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSAGE PREPARATION: The test item was thawed in the refrigerator (+2 - +8°C) overnight. According to the Sponsor, the test item formulation was stable for at least 7 days when stored at +2 - +8°C in the dark. The dose formulation was the undiluted test item.

MAXIMUM DOSE VOLUME APPLIED: Dose volume was 8.09 mL/kg of the undiluted test item.

The starting dose level was based on information from the Sponsor. One female animal was treated with 2000 mg total protein/kg body weight. As no evident signs of toxicity were observed in the animal, the main study was carried out at this dose level.
Doses:
2000 mg total protein/kg body weight
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed 15 minutes and 1, 3, and 6 hours after administration and daily thereafter for 14 consecutive days for clinical signs and weight measured on Days 1, 2, 3, 8, and 15.
- Necropsy of survivors performed: yes

Food was withheld for a 3-hour period after treatment.

Results and discussion

Preliminary study:
One female was dosed at 2000 mg total protein/kg body weight. Animal gained weight during study. No clinical signs were observed. No abnormalities in post-mortem inspection. The preliminary study animal was included in the main study.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs were observed.
Body weight:
Overall body weight gain. One animal lost 5g from Day 2 to Day 3 and one animal had the same body weight on those two days.
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No signs of toxicity were observed among the 5 animals treated with 2000 mg total protein/kg body weight.
Executive summary:

The objective of this study was to assess the toxicity of the test substance when administered as a single oral dose followed by an observation period of 14 days. The study was conducted in accordance with OECD Guideline 420. The study was initiated with a sighting study using one female animal. The dose volume administered was 8.09 mL/kg of the undiluted test item, corresponding to 2000 mg total protein/kg body weight.

 

On the basis of the results of the sighting study, the main study was performed in four additional female rats given a dose of 2000 mg total protein/kg body weight. The total number of animals in the main study included the female animal treated at the same dose level (2000 mg total protein/kg body weight) in the sighting study. No clinical signs were observed among the animals and the body weight gain during the study was normal. The post-mortem inspection of the animals treated with 2000 mg total protein/kg body weight revealed no abnormalities.