Decahydro-2-naphthyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 March 2016 - 12 April 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decahydro-2-naphthyl acetate

EC Number:

234-054-3

EC Name:

Decahydro-2-naphthyl acetate

Cas Number:

10519-11-6

Molecular formula:

C12H20O2

IUPAC Name:

decahydronaphthalen-2-yl acetate

Test animals

Species:

rat

Strain:

other: Sprague-Dawley (Crl:CD(SD)), SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Not reported
- Age at study initiation: 8 weeks old
- Weight at study initiation: 181.6 to 186.8g
- Fasting period before study: Animals were fasted overnight, approximately 16 hours prior to dosing.
- Housing: Animals were individually caged in stainless wire mesh cages (260 x 350 x 210 mm)
- Diet (e.g. ad libitum): Pelleted rodent chow, provided ad libitum approximately 4 hours after dosing.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 to 24.0°C
- Humidity (%): 43.5 to 58.5%
- Air changes (per hr): 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle, 150 to 300 Lux

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

DOSAGE PREPARATION (if unusual): The test substance was weighed and placed in a bottle. A small amount of vehicle was added and mixed using a vortex mixer until dissolved. The vehicle was gradually added to yield the desired concentration.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance, based on the information supplied by the sponsor, a starting dose of 5000 mg/kg was administered in one animal in Step 1 of the study.

Doses:

5000 mg/kg

No. of animals per sex per dose:

1 for Step 1, 2 for Step 2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

Statistical analysis was not performed. Mean scores and values were determined.

Results and discussion

Preliminary study:

In Step 1, the test animal did not die after 3 days.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the duration of the study. There were no effects on mortality.

Clinical signs:

A decrease of fecal volume was observed in all animals on Days 1 and 2 after dosing and it disappeared on Day 3 after dosing. This was considered to be a test substance-related temporary change.

Body weight:

A decrease in body weight was observed in one animal on Day 1 after dosing and a tendency of decreaed body weight gain was observed in two animals on Day 1 after dosing and in one animal on Day 3 after dosing. The animals returned to normal on Days 3 and 7. These changes were considered to be test substance-related effects.

Gross pathology:

No grossly visible evidence of morphological abnormalities were observed in any animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 was determined to be >5000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was determined in a limit test using the acute toxic class method. The test item dose (5000 mg/kg bw) was administered at a volume of 10 mL/kg bw in a corn oil vehicle by oral gavage. One female Sprague-Dawley rat was administered the dose in Step 1 and no mortality was observed after 3 days. Based on this result, two animal were administered the same dose and observed for 14 days. The oral LD50 was determined to be >5000 mg/kg bw. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 423.