Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 5 March 1991 to 28 March 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to the appropriate OECD test guideline and in compliance with 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)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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: Charles River (UK) Ltd, Manston, Kent, UK
- Age at study initiation: 5-8 wk
- Weight at study initiation: 143-161 g (males); 143-154 g (females)
- Fasting period before study: overnight
- Housing: 5/solid floor polypropylene cge, with sawdust bedding
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 37-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: within period 5-28 March 1991

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for death or overt toxicity at 0.5, 1, 2 and 4 h, then daily to day 14; body weights on days 0, 7, 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Statistics:
None required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths recorded. See table 1.
Clinical signs:
No overt clinical toxicity. See table 1.
Body weight:
No treatment-related effect on body weight.
Gross pathology:
No abnormalities detected.
Other findings:
None.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity

Dose
(mg/kg bw)

Mortality (dead/total)

Number with evident toxicity (no./total)

Male

Female

Combined

Male

Female

Combined

2000

0/5

0/5

0/10

0/5

0/5

0/10

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A reliable study conducted in compliance with the standard guideline and in accordance with GLP, found the LD50 to be greater than 2000 mg/kg bw in male and female rats. This value would indicate low acute toxicity by the oral route.