Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study design states it complies and it follows OECD guideline 401 (1987). Contains sufficient detail to suggest GLP-like characteristics, but no statement of certification (reasonably thorough description of authors, dates, design, results, and interpretation)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Appraisal of the safety of chemicals in food, drugs and cosmetics by the staff of the division of pharmacology, FDA (1959)
Deviations:
not specified
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
version of May 1984
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Atrazine technical
Appaerance: white powder
Supplier: OXON Italia S.p.A.

Test animals

Species:
rat
Strain:
other: SPF-Wistar (strain Winkelmann, Pederborn)
Sex:
male/female
Details on test animals and environmental conditions:
For this study SPF-Wister-rates (strain Winkelmann, Paderborn) were used with mean body of 195g. The animals were kept in groups of 5 fameles and 5 males, "at random" divided in single cages. They were fed with a laboratory standard diet and watered ad libitum. the temperature of the room was kept costantly ca 22°C, the relative atmospheric humidity 50-60% and the daily illumination 12 hours. 16 hours before the start of the test the animals were starved.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Doses:
The following dosages of the substance were used for the determination of the LD50:
Group n(sex) Dosage Concentration
I 5 F 5M 1800mg/Kg 18 p.c.
II 5 F 5M 2270mg/Kg 23 p.c.
III 5 F 5M 2860mg/Kg 29 p.c.
IV 5 F 5M 3600mg/Kg 20 p.c.

Concentration was chosen in that way all animals of group I-III received 1 ml per 100 g body weight of solutions, and group IV 1.8 ml per 100 g.
No. of animals per sex per dose:
5 famales and 5 males
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 220 mg/kg bw
95% CL:
5 - 95
Remarks on result:
other: 24 hours
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 960 mg/kg bw
95% CL:
5 - 95
Remarks on result:
other: 14 days
Mortality:
Tables of mortality:
Group 24 hours 7days 14days
I 0/10 1/10 1/10
II 2/10 4/10 4/10
III 4/10 7/10 7/10
IV 10/10 10/10 10/10
Clinical signs:
In all dosage groups the preparation caused apathy, reduced frequence of respiration, and diminished readiness for reflexing. the above mentioned symptoms occured 4 -10 hours post application and continued up to 5 days or caused mortalities.
After 7 days all surviving animals showed except a bristly, rough hair coat and diminished weight gains in groups I -III no remarkable symptoms. All animals of group IV showed coma after 4 hours and died 24 hours.
Body weight:
Development of body weight:
Group Sex starting weight 14 days body weight
I F and M 194.1 - 196.7 232.6 - 243.0
I F and M 192.3 - 195.3 193.7 - 205.9
II F and M 193.1 - 196.9 190 - 202
II F and M 193.7 - 195.9 182.9 - 197.1
III F and M 192.2 - 197 180
III F and M 192.7 - 196.1 185 - 190
IV F and M 194 - 196 -
IV F and M 191.4 - 195.8 -

The surviving animals of dosage groups II and III showed a clearly reduced development of body weights, respectively weightloss.
Other findings:
Autopsy findings:
Neither the acute mortalities nor the animals killed at the end of the test, showed pathological changes in the cranium respectively in the thorax cavity. Intestinal in the acute mortalities hyperaemia was observed. only these findings did also occur in some animals of final autopsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
Atrazine technical was treated in an acute toxicity study after one oral application to the rat.
under the mentioned conditions of the test was found:
1.1 The 24 hours LD 50 was found at 2220 mg of the product per Kg of body weight. Since some late mortalities occurred, the 14-days-LD 50 increased to 1960 mg/Kg of body weight.
1.2 The toxic symptomatic was marked by quick occurring abdominal ache syndrome, exophthalmus, gasping, ataxia, disturbance of coordination and sedation to coma. After some hours resp. days sedation changed to coma. About one half of the animals died within 24 hours post application. The animals surviving 7 days did not die later on by showed weight loss.
Macroscopical adspection during autopsy showed strong hyperaemia of the gastro-intestinal tract in the cases of acute mortalities and also very slight at final autopsy.
No other macroscopical changes in final autopsy occurred.