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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 - 29 Apr 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December 2001
Deviations:
yes
Remarks:
animals were fasted approximately 21 - 22 h prior treatment
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
animals were fasted approximately 21 - 22 h prior treatment
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
animals were fasted approximately 21 - 22 h prior treatment
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cyrene™- Physical state: clear, pale yellow liquid- Analytical purity: 99%- Expiration date of the lot/batch: Sep-2015- Storage condition of test material: At room temperature (20 ± 5 °C)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, B. V., Horst, Netherlands
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 173.2 - 191.7 g (females)
- Fasting period before study: animals were fasted approximately 21 to 22 h prior treatment
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding, including paper enrichment
- Diet: Pelleted Teklad Rat-Mouse Diet 2914C, ad libitum
- Water: Community tap water from Itingen, Switerzland, ad libitum, analysis was performed
- Acclimation period: Five days for group 1, 7 days for group 2 and 12 days for group 3 under laboratory conditions, after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- 15- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE- Concentration in vehicle: The test item was formulated in purified water at a concentration of 0.03 g/mL or 0.2 g/mL.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The dose formulations were prepared shortly before each treatment in tared glass beakers and weighed on a suitable precision balance. The formulations were homogenized using a magnetic stirrer.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3 (300 mg/kg bw), 6 (2000 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for clinical signs: ca. 30 min and 1, 2, 3 and 5 h after treatment on test day 1; once daily during test days 2 - 15; observation of body weight: on test day 1 (prior treatment), 8 and 15
Statistics:
no statistical analysis was performed

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the scheduled treatment.
Clinical signs:
No clinical signs were observed throughout the entire observation period.
Body weight:
No effects on body weight development were noted throughout the study.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study (OECD 423) the LD50 for rats was determined to be >2000 mg/kg bw. There were no mortalities, clinical signs of toxicity or adverse necropsy findings.