Trihexyl benzene-1,2,4-tricarboxylate

Endpoint summary

Description of key information

Not toxic by the oral or dermal routes

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation: 149-163 g for male, 126-140 g for female

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40% w/v

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: Each rat was weighed immediately prior to treatment, 7 and 14 days after post-treatment observation period. The rats were observed each hour to 6hr, after that, 2 times for one day during this time for signs of toxicity.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, organ weights, gross pathology

Statistics:

Not applicable because of no fatality

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

None

Body weight:

The test substance did not cause any changes in body weight.

Gross pathology:

No macroscopic abnormalities that could be attributed to treatment with the test substance were seen on pathological examination.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was evaluated for acute oral toxicity following OECD guideline 401. The test substance was non-toxic in rats at doses up to 2000 mg/kg bw. GHS criteria for acute oral toxicity classification are not met.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

adequate

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Type of coverage:

occlusive

Duration of exposure:

24 h

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 mL/kg bw

Based on:

test mat.

Remarks on result:

other: greater than approx. 2000 mg/kg bw

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 in rabbits for the analogue TOTM is reported to be > 2.0 ml/kg bw, approximately equivalent to 2000 mg/kg bw. The data is applicable for the registered substance, trihexyl trimellitate, and the substance is evaluated as having no hazard for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

An analogue substance for the registered substance was tested for acute oral toxicity in rats, and the LD50 was well over 2000 mg/kg bw; over 10,000 mg/kg bw in some studies. The acute dermal toxicity was over 2000 mg/kg bw in rabbits. The target substance is expected to behave similarly.

Justification for classification or non-classification

The data on acute toxicity do not meet the criteria for classification in Regulation EC No. 1272/2008. The substance is not classifed.