Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.02. - 25.03.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted May 12, 1984
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Appearance: yellow liquid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: CRL:CD (SD) BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein, Switzerland
- Age at study initiation: between 6 weeks
- Weight at study initiation: females and males: 150 -160 g
- Fasting period before study: overnight, prior to dosing
- Housing: five animals per cage in Macrolon cages type 4 with ALTROMIN - soft wood bedding type 3/4
- Diet: ALTROMIN standard diet 1324, ad libitum with exception of the fasting period before treatment start
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 15 - 20 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: from 03 to 25 February 1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle: 10 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: After compound administration the animals were observed for clinical signs of toxicity. Time schedule: 5, 15, 30, 60 minutes; 3, 6 and 24 hours post application, then at least twice daily for a period of 14 days. The onset, duration and intensity of clinical signs of toxicity were recorded.
Mortality check: On administration day several times, then twice daily on 7 days/week.
Body weight: Body weight was recorded before treatment, at week 1 and week 2 after compound administration.
Food consumption: Food consumption was recorded at week 1 and week 2 after compound administration.
Statistics:
Routine evaluation of the data for significance of differences was done by t-test.

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 occurred.
Clinical signs:
In relation to the controls no clinical signs of toxicity were observed in the rats treated with 5000 mg/kg bw.
Body weight:
In comparison to control no statistically significant difference in body weight gain was found in the treated rats.
Gross pathology:
All organs of the rats in the control and dose groups were normal. No effects were observed.
Other findings:
Food consumption:
No difference was found in food consumption between control group and rats treated with 5000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 in male and female Sprague-dawley rats is greater than 5000 mg/kg body weight.
Executive summary:

The acute oral toxicity and the lethal dose (LD50) of the test substance in Sprague-Dawley rats were determined in an OECD 401 guideline study compliant with GLP principles. Two groups of males and females (5/sex/group) were dosed by gavage with 0 and 5000 mg/kg bw of the test substance, controls received the vehicle (olive oil) only. All rats were at least observed twice daily for mortality and clinical signs of toxicity. Body weights were recorded before treatment, at week 1 and week 2 after compound administration; food consumption was recorded at week 1 and week 2 after compound administration. All rats were sacrificed 2 weeks after dosing and a gross post mortem examination was performed. No clinical signs of toxicity were found in the treated animals in relation to the control. All animals survived until the end of the study. No statistical differences were found in body weight gain and no deviations were seen in food consumption between controls and rats treated with 5000 mg/kg bw. At necropsy no alterations were observed in the treated rats. The LD50 in female and male rats was therefore set at > 5000 mg/kg body weight.