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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 Oct 20, 1988 to Nov 30, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles river portage,Michigen, USA
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 116-152 g
- Fasting period before study: Overnight
- Housing: Individually; metal cages with wire mesh floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet(ad libitum)
- Water (e.g. ad libitum): Domestic quality portable water(ad libitum)
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22⁰ C
- Humidity (%): 53%
- Air changes (per hr): Approx 15
- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
Test substance was administered as supplied by the sponsor

MAXIMUM DOSE VOLUME APPLIED: 4.5 mL/kg bw (specific gravity 1.1)
- Rationale for the selection of the starting dose: Preliminary study
Doses:
5000 mg/kg bw (4.54 mL/kg bw)
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
Five males and five females were treated at 5000 mg/kg bw using syringe and plastic catheter (8 choke). Animals were observed after 5 h on day 1 and in subsequent days the animals were observed once in the morning and again at the end of the experiment. Observation period was 14 d.

- Frequency of observations and weighing: Clinical observations done soon after dosing and remainder of Day 1. For the subsequent days observations were done in the morning and at the end of the experimental day.

- Necropsy of survivors performed: Yes along with macroscopic examinations of thoracic, abdominal and cranial cavities. Marcoscopic appearance of abnormal organs was also recorded.

- Other examinations performed: Body weights of each rat was examined at Days 1, 8 and 15 or at death.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality at 5000 mg/kg bw
Clinical signs:
Pilo-erection in all rats within 5 min after dosing which remained for 1 d followed by increased salivation during 1st 2 h after treatment. No other clinical signs were observed and recovery was complete by Day 3.
Body weight:
Slightly low body weight gains during the 1st week (for majority of female rats) and anticipated gain between Day 8 and 15 in all rats.
Other findings:
Terminal autopsy was normal.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test condition, the acute lethal oral dose of di-TMPTTA was > 5,000 mg/kg bw.
Executive summary:

A study was conducted to assess the acute oral toxicity of di-TMPTTA according to OECD Guideline 401 and EU Method B.1, in compliance with GLP. Five males and five females were administered a single oral dose of 5,000 mg/kg bw by gavage. Animals were observed for 14 d. On Day 1, pilo-erection was seen within 5 min of dosing along with increased salivation during 2 h after treatment. Low body weight gain during the first week of the study was recorded but all rats achieved anticipated weight gains between Days 8 and 15. No other clinical signs were observed and recovery, judged by appearance and behaviour, was complete by Day 3. Under the test conditions, the acute lethal oral dose of the test substance was > 5,000 mg/kg bw (Liggett 1989).