1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters

Endpoint summary

Description of key information

- acute oral (OECD 401): LD50 > 2000 mg/kg bw (male / female rats)

 The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 - 25 Jul 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of details on test substance

GLP compliance:

yes (incl. QA statement)

Remarks:

The department of health and social security of the government of the United Kingdom

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd., Kent, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 152-165 g (males), 142-154 g (females)
- Fasting period before study: yes, overnight
- Housing: solid-floor polypropylene cages with sawdust bedding in groups of up to five by sex.
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Ltd., Essex, UK., ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24
- Humidity (%): 47 - 67
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.1 mL/kg

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: several times on the day of application and once daily thereafter.
- Frequency of weighing: on days 0, 7 and 14.
- Necropsy of survivors performed: yes (external examination and opening of the abdominal and thoracic cavities)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Body weight:

other body weight observations

Remarks:

No effect on body weight was noted.

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

One study performed according to OECD 401 under GLP conditions is available to evaluate the acute oral toxicity of 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (CAS 94279-36-4). The acute oral toxicity of the substance (no data on purity) was investigated in 5 Sprague-Dawley rats per sex, which received the undiluted test substance at a limit dose of 2000 mg/kg bw via oral gavage (Croda Europe Ltd., 1991). No mortality occurred during the 14-day observation period and no clinical signs were observed. Based on the results, the oral LD50 value was considered to be greater than 2000 mg/kg bw. Thus, no hazard for acute oral toxicity was identified and the available data indicate a very low level of acute oral toxicity for the registered substance.

Justification for classification or non-classification

The available data on acute oral toxicity with 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.