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

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 401: > 2075 mg/kg bw.

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:

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

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

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

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).

Preliminary study:

Preliminary study showed no mortalities.

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.

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).

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

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).

Justification for selection of acute toxicity – oral endpoint
The result of this study is reliable and adequate for covering this endpoint.

Justification for classification or non-classification

According to the criteria outlined in Annex I of 67/548/EEC (DSD) and Annex VI of 1272/2008/EC (CLP), the substance does not have to be classified as acute toxic by the oral route.