Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 August 1983 to 7 September 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to acceptable standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The compound as supplied was administered as a single dose by gavage to 4 rats which had been fasted for 18 hours, at a rate of 10 ml/kg.
GLP compliance:
not specified
Test type:
other: Not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name: triisodecylbenzene-1,2,4-tricarboxylate
Appearance: pale yellow liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Healthy Sprague Dawley RAI f (SPFTif) derived rats, bred on the premises, or imported from CIBA-GEIGY Limited, Basle, Switzerland,. aged 5-6 weeks, having an average body weight of 180 g (2 males) and 145 g (2 females).

Husbandry
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (± 2°C). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial autoclavable pelleted diet (Labsure CRM rat and mouse) was fed ad lib. Filtered water was available at all times.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The compound as supplied was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 10 ml/kg.
Doses:
10 ml/kg
No. of animals per sex per dose:
2 per sex per dose
Control animals:
no
Details on study design:
Observations
After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 590 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
No data
Gross pathology:
No abnormalities were seen throughout the 14 day observation period nor at terminal autopsy.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the substance in rats was greater than 10 ml/kg bw (> 9590 mg/kg bw).
Executive summary:

The acute oral median lethal dose (LD50) of the substance in rats (2 male and 2 female) was greater than 10 ml/kg bw (> 9590 mg/kg bw).