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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
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
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
animals were fasted approximately 21 - 22 h prior treatment
Qualifier:
according to guideline
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

Constituent 1
Chemical structure
Reference substance name:
(1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one
EC Number:
807-130-4
Cas Number:
53716-82-8
Molecular formula:
C6H8O3
IUPAC Name:
(1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one
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 or test system 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 the acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, the LD50 value for female rats was determined to be greater than 2000 mg/kg bw. There were no mortalities, clinical signs of toxicity or adverse necropsy findings.