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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with internationally recognised test methods. For read across justification see Section 13.

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
Reference substance name:
Trioctyl trimellitate
IUPAC Name:
Trioctyl trimellitate
Details on test material:
- Name of test material (as cited in study report): Trioctyl benzene-1,2,4-tricarboxyiate
- Molecular formula (if other than submission substance): C33 H54 O6
- Molecular weight (if other than submission substance): 546.79
- Smiles notation (if other than submission substance): O=C(OCCCCCCCC)c(ccc(c1C(=O)OCCCCCCCC)C(=O)OCCCCCCCC)c1
- InChl (if other than submission substance): 1S/C27H42O6/c1-3-5-7-9-11-12-14-16-20-33-27(31)23-18-17-22(21-24 (23)25(28)29)26(30)32-19-15-13-10-8-6-4-2/h17-18,21H,3-16,19-20H2,1-2H3, (H,28,29)
- Structural formula attached as image file (if other than submission substance): see 89-04-3 structure.png

- Physical state: liquid
- Analytical purity: => 99.0%
- Lot/batch No.: C-120
- Stability under test conditions: Stated to be stable
- Storage condition of test material: Ambient conditions

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 decribed 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