Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane-1,2-diol and glycerol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is pre-GLP and pre-OECD guidelines. The study has been performed according to a method similar to OECD 401

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Pre-guideline study. Three doses suspended in 2% CMC were applied by gavage to each 5 male and 5 female rats. Observation period was 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

solid - liquid: suspension

Remarks:

migrated information: dispersion

Details on test material:

Test material dispersed in 2% Carboxymethylcellulose
- Physical state: solid, dispersed in 2% CMC

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: raised in-house at Ciba-Geigy Ltd. Switzerland, Sisseln
- Weight at study initiation: 160 to 180 grams
- Fasting period before study: overnight
- Housing: Macrolon cages type 3, groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hours dark, 10 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30%

Doses:

4640 mg/kg bw, 6000 mg/kg bw, 7750 mg/kg bw,

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After 1 and 2 hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology of organs

Statistics:

LD50 including 95% confidence limits were calculated with the logit model

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 6 231 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 5 723 - <= 6 957

Mortality:

Animals started to die after 7 days at 6000 mg/kg bw
Animals started to die after 24 hours at 7750 mg/kg bw

Clinical signs:

sedation, dyspnoea, exophtahlmos, curved positiona and ruffled fur

Body weight:

no data

Gross pathology:

no substance-related deviations from normal morphology observed in organs

Any other information on results incl. tables

Dose Died within mg/kg bw 1 hour 24 hours 48 hours 7 days 14 days m f m f m f m f m f 4640 5 5 0 0 0 0 0 0 0 0 6000 5 5 0 0 0 0 2 1 2 1 7750 5 5 1 0 2 2 5 5 5 5

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 in the rat is about 6200 mg/kg bw and similar in both sexes.

Executive summary:

The LD50 oral in the rat is ca. 6200 mg/kg bw.