tris(2-octyldodecyl) citrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Both the source and target substances in this read across are mono-constituent substances composed of the
same chemical groups and linked together in functionally the same way. The impurities present in both
substances are structurally similar to the source and target substances and are not expected to impact on the
predicted result, or reliability of the predicted result.
No toxicological effects were observed during the acute toxicity study conducted on the source substance. The
acute oral LD50 was set at >5000 mg/kg bw based upon the test dose of 5000 mg/kg bw. Due to the structural
and functional similarities between the source and target substances the predicted acute oral toxicity result of
the target substance is also negative. The target substance fails to meet Lipinski’s rule of five, and is therefore
unlikely to be orally active (bioavailable). The acute oral toxicity potential of the target substance is expected to
be the same as the source substance. The predicted result is therefore considered by the registrant to be
acceptable for registration, classification and labelling, and PBT/vPvB purposes.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Read across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Study conducted before GLP was adopted in USA.

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trihexadecyl citrate

EC Number:

224-931-9

EC Name:

Trihexadecyl citrate

Cas Number:

4560-68-3

Molecular formula:

C55H106O6

IUPAC Name:

trihexadecyl citrate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Albino (not otherwise specified).

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 218-260 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was used as received (sp.g. = 0.92).

Doses:

5 g/kg bw

No. of animals per sex per dose:

5 male 5 female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 3, 6 and 24 hours and then daily
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacologic activity and drug toxicity

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study period.

Clinical signs:

other: No clinical signs were reported.

Gross pathology:

No effects were observed during necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article was determined to have an acute oral LD50 of >5000 mg/kg bw in rats under the conditions of the test.

Executive summary:

In this study (equivalent to EPA OPPTS 870.1100), the test article was determined to have an acute oral LD50 of >5000 mg/kg bw in rats under the conditions of the test.