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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1989-04-19 to 1989-05-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): WITAMOL 218
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young healthy adults, no further details mentioned
- Weight at study initiation: 113 g (mean)
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 5 - 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1989-04-19 To: 1989-05-03

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.06 cm³/kg

DOSAGE PREPARATION (if unusual): test substance was applied undiluted
Doses:
3000 mg/kg body weight
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: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
The means of the body weights were calculated.
The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
0/10
Clinical signs:
no clinical effects observed
Body weight:
body weight gain was unaffected
Gross pathology:
no changes of organs macroscopically visible
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the study performed the LD50 to rats of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was found to be > 3000 mg/kg bodyweight.
Executive summary:

A study was performed to assess the acute oral toxicity of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters to the rat. A group of 10 rats (5 male and 5 female) was given a single oral application of the test substance at a dose level of 3000 mg/kg bodyweight. The undiluted liquid test substance was administered by gavage using a stomach tube with an application volume at 3.06 cm³/kg bodyweight.

There were no deaths and no signs of systemic reaction to treatment. All animals achieved satisfactory bodyweight gains throughout the study.

The rats were killed and examind macroscopically on day 14, the end of the observation period. The macroscopical examination revealed no abnormalities.

The dosis letalis media (LD50 oral) to male and female rats of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was found to be > 3000 mg/kg.