Simazine

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Simazine

EC Number:

204-535-2

EC Name:

Simazine

Cas Number:

122-34-9

Molecular formula:

C7H12ClN5

IUPAC Name:

6-chloro-N2,N4-diethyl-1,3,5-triazine-2,4-diamine

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 or test system 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.