Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics" by the Staff of the Division of Pharmacology, FDA, 1959 and OECD Guidelines for Toxicology of Chemicals, 1981
Deviations:
no
GLP compliance:
no
Remarks:
Although the study predates GLP, the appendix in the report states that the experiment was carried out in accordance with GLP and OECD Guidelines.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Test material: Simazine Technical
- Description: White powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany
- Weight at study initiation: 200 g (mean bodyweight)
- Fasting period before study: 16 hours
- Housing: single cages
- Diet (e.g. ad libitum): Laboratory standard diet
- Water: available ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 1°C
- Humidity (%): 50 - 60%
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1%

MAXIMUM DOSE VOLUME APPLIED: 2.06 mL
Doses:
2500, 5000 and 7500 mg/kg bw
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were measured at the start and end of the experiment. Mortalities were assessed 24 hours, 48 hours and 7 days after exposure. Clinical observations were made 7 and 14 days after exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic analysis

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred during the study.
Clinical signs:
In all dosage groups, the preparation caused slight apathy, reduced frequency of respiration and diminished readiness for reflexing, 10-24 hours post application. After 7 days, no remarkable symptoms were observed.
Body weight:
All animals showed a slight reduction in bodyweight compared to normal gains within the laboratory.
Gross pathology:
Slight hyperaemia of the gastro-intestinal tract was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortalities were observed throughout the study. The LD50 for acute oral toxicity is therefore >7500 mg/kg bw.