1,8-Naphthalenediol, 1,8-dibenzoate

Endpoint summary

Description of key information

OECD 423 (BASF Corporation, 2014): LD50 oral >2000 mg/kg bw in rats

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class method (BASF Corporation, 2014), 2000 mg/kg bw of the test item Thane 003-6 (preparations in corn oil Ph. Eur.) were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females). No mortality occurred, no clinical signs were observed. The mean body weight increased within the normal range throughout the study period. There were no macroscopic pathological findings at the end of the observation period.

The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Guideline and GLP study

Justification for classification or non-classification

Based on the available data, 1,8 -Naphthalenediol, 1,8 -dibenzoate (Thane 003 -6) does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008 (CLP/GHS).