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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:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

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: Interfauna U.K. Limited, Wyton, Huntingdon, U.K.
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: 120-127 g (males), 135-150 g (females)
- Fasting period: food was removed at day -1 and then redistributed 2 hours after treatment
- Housing: polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diets Services Ltd., Witham, Essex, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 50-65 %
- Air changes: approximately 10 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 18-Sep-1985 To: 08-Oct-1985

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The animals received a dose of 5000 mg/kg bw of the test item administered by gavage (dose volume: 5.62 mL/kg bw) using a metal cannula attached to a graduated syringe. The dose level for each animal was calculated according to its body weight at the time of dosing.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded 1 and 4 hours after dosing and then once daily for 14 days, body weight was measured on days 0 (day of treatment), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic observation

Results and discussion

Preliminary study:
No mortality was noted 5 days after dosing. The oral LD50 of the test item was considered to be >5000 mg/kg bw. This dose level was used for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
There was no mortality.
Clinical signs:
Hunched posture and piloerection were observed in all treated animals 1 hour after dosing. Other signs of overt toxicity seen in some animals only at this time consisted of lethargy, ataxia and a decreased respiratory rate. All males and one female continued to show hunched posture and piloerection at the 4-hour observation. This female also showed ataxia at this time. Recovery of all animals was apparently complete by day 1.
Body weight:
All animals showed normal gains in body weight during the study period.
Gross pathology:
There were no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:
other: slightly toxic
Executive summary:

In an acute oral toxicity study (Jones & Collier, 1985), a group of fasted young adult Sprague-Dawley rats (5 males, 5 females) were given a single dose of ZD 8 Gewaschen by oral gavage at a dose level of 5000 mg/kg bw and observed for 14 days. There was no mortality or other relevant findings. The oral LD50 (males and females) was >5000 mg/kg bw.

ZD 8 Gewaschen is of low toxicity based on the LD50 in male and female rats.