1,8-Naphthalenediol, 1,8-dibenzoate

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

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

Test material information

Constituent 1

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.