4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 21, 1990 to July 05, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP 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:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)

EC Number:

407-410-2

EC Name:

4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)

Molecular formula:

C28H40O8

IUPAC Name:

2-[({5-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-8-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid; 2-[({8-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-4-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid

Constituent 2

Reference substance name:

TCD- emulsifier

IUPAC Name:

TCD- emulsifier

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): TCD-Emulgator; Tricyclododecandioldihexahydrophtalatdicarbonacid)
- Physical state: solid
- Analytical purity: 95.7 %
- Impurities (identity and concentrations): TCD-Diol: 0.6 % (w/w), Hexahydrophtalsäure: 1.3 % (w/w)
- Purity test date: Apr. 18, 1990-May 04, 1990
- Lot/batch No.: 90003
- Expiration date of the lot/batch: Jan. 08, 1992
- Storage condition of test material: At room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males: about 8 weeks, females: about 10 weeks
- Weight at study initiation: males: 188 g, females: 179 g (mean deviation < 20 % for both)
- Fasting period before study: 16 hours before and up to 4 hours after application
- Housing: groups of 5 under conventional conditions
- Diet: fixed-formula standard diet
- Water: ad libitum
- Acclimation period: 6 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark/hrs light): 12 hrs dark/12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): Constant application volume = 10 ml/kg bw

Doses:

2000 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 and weighing: Inspection: twice daily (once on weekends and holidays), several times on day of administration; weighing: once a week until end of observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the 14-day observation period.

Clinical signs:

After single administration of 2000 mg/kg no clinical signs were observed.

Body weight:

Growth was not retarded in male and female rats.

Gross pathology:

There were no gross pathological findings in any of the male and female animals of the dose 2000 mg/kg sacrificed at the end of study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the observation that no acute toxic effects were observed during the present study the test item is not classified.

Executive summary:

In an acute oral toxicity study, groups of 8 week old male and 10 week old female Wistar rats (5/sex) were given a single oral dose of the test item in polyethylene glycol 400 at 2000  mg/kg bw and observed for 14 days.

No mortality occurred at the limit dose of 2000 mg/kg bw.

The test item not classified toxic based on a LD0 ≥ 2000 mg/kg.

There were no treatment related clinical signs, necropsy findings or changes in body weight.