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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:
19.09. - 17.10.1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24. February 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical properties: liquid
- Storage conditions: room temperature

Test animals

Species:
rat
Strain:
other: Tif:RAIf
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein, Switzerland
- Weight at study initiation: 183 to 200 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Macrolon cages type 4
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 01.10. to 17.10.1991

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % (w/v) in 0.1 % (w/v) aqueous polysorbate 80
Details on oral exposure:
Volume applied: 10 mL/kg body weight
Doses:
2000 mg/kg bw (males and females)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:
Mortality : daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14
Statistics:
Group means and respective standard deviations were calculated of body weights.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred
Mortality:
No mortality occurred in this study.
Clinical signs:
Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 5 days.
Body weight:
The body weight was not affected adversely.
Gross pathology:
At autopsy, no deviations from normal morphology were found

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The oral LD50 value of the test article in rats was established to exceed 2000 mg/kg body weight.
Executive summary:

In an oral toxicity study according to OECD guideline 401, five male and five female Tif: RAIf rats were dosed once with the test article in the vehicle (0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate80) by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the observation period. No mortalities were recorded. Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 5 days. At autopsy, no deviations from normal morphology were found. The oral LD50 value of the test article was established to exceed 2000 mg/kg body weight.