Registration Dossier

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

Constituent 1
Chemical structure
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.