Octahydro-4,7-methano-1H-indene-5-methanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Initiation: 25 May 1983 - Termination: 14 June 1983.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octahydro-4,7-methano-1H-indene-5-methanol

EC Number:

260-789-4

EC Name:

Octahydro-4,7-methano-1H-indene-5-methanol

Cas Number:

57526-50-8

Molecular formula:

C11H18O

IUPAC Name:

{tricyclo[5.2.1.0²,⁶]decan-8-yl}methanol

Test material form:

liquid

Specific details on test material used for the study:

No information on purity. However, as it is stated in the section 13, the substance and its composition have remained essentially the same over the last decades.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean value for males and females: 212 g (range males 192-228 g; range females 187-243 g)
- Fasting period before study: 16 hours
- Housing: in groups of 5 per sex per cage
- Diet: rat diet Altromin 1324, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 hours per day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 6.4, 8, 10, 16, 20 mL/kg bw, respectively
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

1600, 2000, 2500, 4000, 5000 mg/kg bw

No. of animals per sex per dose:

5 except for 2000 mg/kg bw (only 5 females) and 5000 mg/kg bw (only 5 males)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 calculation by probit analysis according to Lindner and Weber

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

3 350 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 400 - 4 390

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

2 270 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 800 - 3 030

Mortality:

see below

Clinical signs:

other: see below

Gross pathology:

see below

Any other information on results incl. tables

RS-Freetext:
Male rats: LD50 = 3350 mg/kg bw
Female rats: LD50 = 2270 mg/kg bw

Mortality: male -- female rats
1600 mg   0/5 -- 1/5
2000 mg    -   -- 0/5
2500 mg   1/5 -- 4/5 
4000 mg   3/5 -- 5/5
5000 mg   5/5 --   -   

Signs of intoxication: 
A narcotic-like behaviour was noted. All animals showed disorders of  balance, lethargic behaviour and prone position. Animals died within 1-2  days post application in narcosis. 
Survivors returned to weakness and showed piloerection, easily  frightened, increased lacrimation and bad general condition.

Gross pathological examination:
The macroscopic examination of surviving animals gave no adverse effects.  Animals that died before study determination showed grey-red discoloured  lungs, brightened liver with increased pattern, adrenal glands were of  dark brown colour, small intestine looked glassy and was partially filled  with blood.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the experimental data an oral LD50 of 3350 and 2270 mg/kg bw was calculated for males and females, respectively.

Executive summary:

In a GLP OECD guideline study (TG 401) acute toxicity of the test item was investigated (n= 5 males and females per dose group). Rats received single oral doses of the test item in sesame oil by gavage and were observed for 14 days thereafter. Clinical signs were a narcotic like behaviour, disorders of balance, lethargic behaviour and prone position. Animals died within 1 -2 days post application in narcosis. Survivors returned to weakness and showed piloerection, easily frightened, increased lacrimation and bad general condition. Based on the experimental data an oral LD50 of 3350 and 2270 mg/kg bw was calculated for males and females, respectively.