Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trioctyl benzene-1,2,4-tricarboxylate
EC Number:
201-877-4
EC Name:
Trioctyl benzene-1,2,4-tricarboxylate
Cas Number:
89-04-3
Molecular formula:
C33H54O6
IUPAC Name:
1,2,4-trioctyl benzene-1,2,4-tricarboxylate
Test material form:
liquid
Specific details on test material used for the study:
- Lot/batch No.: C-120

Test animals

Species:
rat
Strain:
other: Crj:CD (SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: males: 116-127 g; females: 97-108 g
- Fasting period before study: 18 hours
- Housing: 5 same sex in stainless steel breeding cages
- Diet (e.g. ad libitum): yes, except during pre-dose fasting period
- Water (e.g. ad libitum): yes
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/- 2 degrees C
- Humidity (%): 55+/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12: 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% w/v
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Substance is not miscible in aqueous vehicles but is water miscible in oil

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): liquid test substance mixed with vehicle

Doses:
2000 mg/kg (based on findings of preliminary study in which doses of 1000 and 2000 mg/kg did not cause mortality).
No. of animals per sex per dose:
5 males & 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently for 6 hours on day of dosing then daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight - Days 1, 2, 4, 8, 11 and 15
Statistics:
Student t-test applied to bodyweight data control vs. test groups

Results and discussion

Preliminary study:
In preliminary study 1000 and 2000 mg/kg did not cause mortality.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths occurred
Mortality:
None in controls or test group
Clinical signs:
other: Mucoid faeces were seen in animals from both control and test groups 1-3 hours after dosing. The incidence between groups was similar.
Gross pathology:
There were no abnormalities noted in any animal from either control or treatment group.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose (LD50) in the rat was established at > 2,000 mg/kg for both sexes.
Executive summary:

Acute oral toxicity has been investigated in the rat using methods described in OECD TG 401. No mortality or effects of treatment occurred following administration of a single dose at a level of 2000 mg/kg body weight. The median lethal dose (LD50) in the rat is therefore in excess of 2000 mg/kg