Octahydro-4,7-methano-1H-indenecarbaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 April 1988 - 3 June 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability 1 is assigned because the study is conducted according to OECD 401 guideline and in compliance with GLP, without deviations that influence the quality of the results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octahydro-4,7-methano-1H-indenecarbaldehyde

EC Number:

250-333-2

EC Name:

Octahydro-4,7-methano-1H-indenecarbaldehyde

Cas Number:

30772-79-3

Molecular formula:

C11H16O

IUPAC Name:

(1R,2S,3S,6R,7S)-tricyclo[5.2.1.0²,⁶]decane-3-carbaldehyde; bis((1R,2S,4R,6R,7S)-tricyclo[5.2.1.0²,⁶]decane-4-carbaldehyde)

Test material form:

other: colourless, clear, slightly oily liquid

Details on test material:

- Name of test material (as cited in study report): Formyltricyclodecan
- Storage condition of test material: at normal room temperature, in darkness.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld
- Weight at study initiation: males 217-223 g, females: 170-188 g
- Fasting period before study: 16 hours
- Housing: collective caging (max. 5) in Macrolon type III cages
- Diet: ad libitum, pellets (Ssniff-R diet for rats only)
- Water: ad libitum, tap water
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2
- Humidity (%): 50-80
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: May 6th 1988 To: May 25th 1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.45 mL (dosing 2 ml/kg bw, density = 1.0374)

Doses:

2075 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical signs were observed 10 minutes, 30 minutes, 1 hours, 2 hours, 3 hours, 6 hours, 24 hours, 48 hours and afterwards daily up to day 14. Body weights were recorded on day 0 and 14 (termination).
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight, gross necropsy (cranial, thoracic and abdominal cavities).

Results and discussion

Preliminary study:

Preliminary study showed no mortalities.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Mortality:

No mortality was observed.

Clinical signs:

other: Slight reduced activity (apathy), partly obvious disturbance of coordination with abnormal body posture. First symptoms were observed 10 minutes after administration and lasted up to 6 hours in decreasing intensity. No clinical signs were noted after this

Gross pathology:

Necropsy showed no macroscopic findings in the cranial, thoracic and abdominal cavities.

Any other information on results incl. tables

Results of the preliminary study indicated that the acute median lethal oral dose of the test substance was >2000 mg/kg bw, as no mortality was observed in the treated animals (2 females).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity test showed an LD50 of >2000 mg/kg bw. Based on these results, the substance does not need to be classified for acute oral toxicity according to EU classification criteria.

Executive summary:

In this study, 10 rats (5 males and 5 females) were administered the substance at a single dose level of 2075 mg/kg bw. The rats showed no mortality, but some clinical signs were noted from 10 minutes up to 6 hours after treatment. A body weight increase was noted in all rats during the observation period (14 days). Necropsy was performed by opening the abdominal-, cranial- and thoracic cavity, but no abnormalities were found. The acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw (>2075 mg/kg bw).