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

Endpoint summary

Description of key information

The oral LD50 for male and female rats is 3350 and 2270 for male and female rats, respectively.

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

Study period:

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

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

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.

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

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

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

3 350 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 400 - 4 390

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 270 mg/kg bw

Quality of whole database:

GLP guideline study available

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 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.

Justification for classification or non-classification

Based on the experimental results the substance has not to be classified for acute oral toxicity according to Regulation (EC) No. 1272/2008.

A classification for acute oral toxicity Cat. 5 has to be performed according to the United-Nations Globally Harmonized System of Classification and Labelling (UN-GHS, 7th revised version, 2017).