Registration Dossier

Diss Factsheets

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:
other: Guideline and GLP 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)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
8-(benzoyloxy)naphthalen-1-yl benzoate
EC Number:
810-797-4
Cas Number:
331711-99-0
Molecular formula:
C24 H16 O4
IUPAC Name:
8-(benzoyloxy)naphthalen-1-yl benzoate
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Thane 003-6
- Physical state: beige to brown solid
- Analytical purity: 98.153% (determined by non-GLP HPLC)
- Purity test date: 98.153 area-%
- Batch No.: LJ-008-09-136
- Test item No.: 13/0254-1
- Homogeneity: The test item was homogeneous by visual inspection.
- Storage condition of test material: Room temperature, protect against humidity
- Expiry date: June 2016

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation (g): group 1: 176.3 (+/- 1.53); group 2: 174.3 (+/- 1.15)
- Fasting period before study: yes, at least 16 hours prior to administration
- Housing: single housing in makrolon cage, Type III
- Diet: ad libitum VRF1(P); SDS Special Diets Service, Altrip, Germany
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40g/100ml
- Amount of vehicle (if gavage): 5 ml/kg
- Justification for choice of vehicle: good homogeneity in corn oil

DOSAGE PREPARATION (if unusual):The test item preparation was produced for each application group shortly before application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally the homogeneity of the test item preparation during application was ensured by stirring with a magnetic stirrer.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: low toxicity was expected
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Application group 1: 3 animals
Application group 2: 3 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration and at least once during each workday thereafter
- Frequency of weighing: shortly before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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 occured in both administration groups
Clinical signs:
other: In both test groups no clinical signs were observed during clinical examination.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion