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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

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.