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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Remarks:
Centre International de Toxicologie, France
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6 DCPTFMA
- Physical state: solid
- Storage condition of test material: room temperature

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: about 6 weeks old
- Weight at study initiation: mean: male: 166 ± 7, female: 138 ± 4
- Fasting period before study: approximately 18 hours
- Housing: 5 animals of the same sex per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
880, 1300, 2000 mg/kg bw.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were individually weighed just before administration of the test substance and then on days 5, 8 and 15. The animals were checked frequently for mortality just after administration of the test substance and at least twice a day during the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
1 610 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
2 484 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 978 mg/kg bw
Based on:
test mat.
95% CL:
1 519 - 6 369
Mortality:
In males, there were 0%, 0% and 20% mortalities at 880, 1300 and 2000 mg/kg. The male died 24 hours post-dosing. In females, there were 0%, 0% and 100% mortalities at 880, 1300 and 2000 mg/kg. The animals died on days 2 or 3.
Clinical signs:
The onset of clinical signs occurred 15 minutes after administration of the test substance. At all dose levels, the clinical signs of toxicity which were observed were as follows:
- at 880 mg/kg: hypokinesia and dyspnoea for 2 hours post-treatment then hypokinesia for 24 hours post-treatment.
- at 1300 mg/kg: hypokinesia or sedation and dyspnoea for 24 hours posttreatment. In a few animals, coma was noted after 24 hours. Only hypokinesia persisted after 48 hours.
- at 2000 mg/kg, hypokinesia or sedation and dyspnoea for 24 hours posttreatment. In a few animals, coma was noted after 24 hours. The behaviour of the surviving animals returned to normal on day 5.
Body weight:
Between days 1 and 5, the body weight gain of males given 1300 and 2000 mg/kg had slowed down. Subsequently, the body weight gain was similar
to that of historical controls. The body weight gain of the other surviving animals was similar to that of historical controls between days 1 and 15.
Gross pathology:
Macroscopic post-mortem examination performed on the animals that died during the study or were sacrificed at the end of the study, revealed no
abnormalities. Due to the absence of macroscopic lesions, no samples were taken for histological examinations.

Applicant's summary and conclusion