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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:
End of the study: 02/04/1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
other: Acute Oral Toxicity
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle. France.
- Age at study initiation: 6 weeks old
- Weight at study initiation: 185 +/- 7g for the males, 149 +/- 7 g for the females
- Fasting period before study: 18 hours, they were then given food 4 hours after treatment.
- Housing: The animals were housed in groups of 4 to 7 animals of the same sex in polycarbonate cages (48x27x20 cm) during the acclimatization period and groups of 5 animals of the same sex during the study.
- Food consumption (e.g. ad libitum): ad libitum
- Water consumption (e.g. ad libitum): ad libitum
- Acclimation period: 5 days during which they were observed daily.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20% relative humidity
- Air changes (per hr): the air was non-recycled and filtered by absolute filters.
- Photoperiod (hrs dark / hrs light): 12hr/12hr

In-life dates: From 12/12/1991 to 13/02/1992


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: paraffin oil
Details on oral exposure:
VEHICLE
A different vehicle (water for injections) was used for the preliminary assay.
- Batch n°: 1336 for water for injections (preliminary assay) and batch n°: 6852 for paraffin oil (main assay)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg



Doses:
preliminary assay: 2000 mg/kg bw
main assay: 490, 680, 880, 1200 mg/kg bw (males) and 680, 880 mg/kg bw (females)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed frequently after administration of the test substance and at least once a day for clinical signs and at least twice a day for mortality.
- Frequency of weighing: Animals were weighed just before administration of the test substance and then on days 5, 8 and 15.
- Necropsy of survivors performed: yes on day 15
- Other examinations performed: macroscopic examination at necropsy (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities)
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
815 mg/kg bw
95% CL:
643 - 1 049
Mortality:
Mortality was observed within the 24 hours of administration of the test substance. No sex-related differences were noted.
At the dose level of 2000 mg/kg, all animals found dead.
The mortality in males was 0%, 20%, 60% and 100% at the dose levels of 490, 680, 880 and 1200 mg/kg respectively. The mortality in females was 0% and 60% at the dose levels of 680 and 880 mg/kg respectively.
Clinical signs:
Following administration of the test substance, a severe decrease in spontaneous activity accompanied by piloerection and dypsnea were seen at all dose levels. Other clinical signs noted in a few animals were hypersalivation and coma. Clinical signs were reversible between days 8 and 14.
Body weight:
Decreased body weight gain, sometimes resulting in slight to severe body weight loss, was observed between days 1 and 5 at all dose levels. Body weight gain returned to normal thereafter.
Gross pathology:
At necropsy of the animals found dead during the study, signs of ulceration of the stomach were observed at all dose levels. The macroscopic examination revealed no abnormalities in the animals sacrified at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
TBC 100% ECAILLES is considered as harmful if swallowed.

EU GHS Classification:
Acute oral toxicity Cat. 4 (H302)
Executive summary:

In an acute oral toxicity study (CIT study, 7674 TAR, 1992), groups of 6 weeks old fasted Sprague-Dawley rats (5/sex) were given a single oral dose of 4 -tert-butylpyrocatechol (100% Ecailles) in paraffin oil at doses of 490, 680, 880 and 1200 mg/kg bw for males and at doses of 680 and 880 mg/kg bw for females. Animals were observed for 14 days.

Oral LD50 Males = 815 mg/kg bw (95% C.I.: 643 - 1049 mg/kg)

4 -tert-butylpyrocatechol is harmful based on the LD50 in males.

The mortality in males was 0%, 20%, 60%, 100%, and 100% at the dose levels of 490, 680, 880, 1200 and 2000 mg/kg respectively. The mortality in the females was 0%, 60% and 100% at 680, 880 and 2000 mg/kg respectively. The necropsy of animals found dead showed signs of ulceration of the stomach at all dose levels. The macroscopic observation revealed no abnormalities in the animals sacrified at the end of the study. The observed decrease in body weight gain, sometimes resulting in body weight loss, in few surviving animals returned to normal after day 5. It can be stated that, according to the results, the LD50 in the females was similar to that of males.

This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study (OECD 401) in the rats.