4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Feb - 06 Mar 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1981)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin

EC Number:

241-997-4

EC Name:

4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin

Cas Number:

18096-62-3

Molecular formula:

C11H12O2

IUPAC Name:

2H,4H,4aH,5H,9bH-indeno[1,2-d][1,3]dioxine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 120 - 139 g; females: 122 - 138 g
- Housing: animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K., ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 39 - 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

Preliminary study: 25, 200, 2000 and 5000 mg/kg bw
Main study: 2000 mg/kg bw

No. of animals per sex per dose:

Preliminary study: 1
Main study: 5

Control animals:

no

Details on study design:

Preliminary study:
- Duration of observation period following administration: 5 days
- Frequency of observations: Animals were observed 1 and 4 hours after dosing and then daily for 5 days.
- Necropsy of survivors performed: no

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths and evidence of overt toxicity 1 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Preliminary study:

The female rat dosed with 5000 mg/kg bw died on day 1. All other animals survived until the end of the study. From this mortality data the oral LD50 was considered to be approximately 5000 mg/kg bw and a dose level of 2000 mg/kg bw was selected for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed until the end of the study.

Clinical signs:

other: Common signs of toxicity noted on the first day were hunched posture, lethargy, piloerection, decreased respiratory rate and ataxia.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was found.