[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 10 to October 31, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD test guideline No. 401 but not following GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

EC Number:

229-861-2

EC Name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Cas Number:

6790-58-5

Molecular formula:

C16H28O

IUPAC Name:

(3aR,5aS,9aS,9bR)-3a,6,6,9a-tetramethyl-dodecahydronaphtho[2,1-b]furan

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Fü-Albino outbred stock Ibm:RORO (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Biological Research Laboratories (BRL) CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: no data
- Weight at study initiation: M: 124.5-140 g ; F: 117-126 g
- Fasting period before study: overnight before treatment, animals were given food again 4 hours after application of the test compound.
- Housing: max 3 per cage
- Diet (e.g. ad libitum): KLIBA 25-343, complete rodent maintenance diet ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 30, 60, 120 and 240 minutes after application and then daily
- Weighing: immediately before treatment and on day 7 and 14.
- Necropsy of survivors performed: yes (CO2 asphyxia)

Statistics:

none

Results and discussion

Preliminary study:

Not applicable

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: None

Gross pathology:

No pathological changes

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Oral LD50 Combined > 2000 mg/kg bw

Executive summary:

In an acute oral toxicity study performed according to OECD test Guideline No 401, groups of Fü-Albino outbred stock Ibm:RORO (SPF) rats (5/sex) were administered a single oral dose of 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs, behaviour and appearance and then necropsied for macroscopic observations. 5 control rats per sex received a standard suspension vehicle.

None of the animals died during the study. No clinical signs were noted and weight gain was within normal range. No signs of gross pathological change were found by necropsy.

Oral LD₅₀Combined > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint