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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
08. Feb. 1978 - 17. Mar. 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline studies with acceptable restrictions performed on analogue substance 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
BASF-Test. In principle, the methods described in OECD Guideline 401 were used.5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in water. Group-wise documentation of clinical signs was performed over the 7 day study period. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
GLP compliance:
no
Test type:
standard acute method

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- Weight at study initiation: male: 210 (mean), female: 160 (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE- Concentration in vehicle: 5000 mg/kg: 50%3160 mg/kg: 31.6%2150 mg/kg: 21.5%1470 mg/kg: 14.7%
Doses:
5000mg/kg, 3160 mg/kg, 2150 mg/kg, 1470 mg/kg
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations: daily- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 800 mg/kg bw
Mortality:
5000 mg/kg: 1 male and 1 female died within 5 days, 1 male and 3 females died within 6 days and 1 male and 1 female died on day 7.3160 mg/kg: 1 male died within day 3 and 1 within day 6. 1 female died on day 7.2150 mg/kg: No mortality was observed.1470 mg/kg: 1 female died within 4 days.
Clinical signs:
Poor general state in the 1st week of the study. Occurrence of death and loss of weight at the end of the 1st week of the study. 5000 mg/kg: Immediately after the application: apathy, irregular respiration, tumbling, spastic gait, discoloured urine (orange). 2 days post exposure: fur was smeared with feces. 6 days post exposure exsiccosis was noted.3160 mg/kg: Immediately after the application: discoloured urine (orange). 5 days post exposure apathy, abdominal position and exsiccosis was noted.2150 mg/kg: discoloured urine (orange).1470 mg/kg: on the first day post application irregular respiration, apathy, spastic gait and discoloured urine (orange) was noted.
Gross pathology:
Animals that died spontaneously:5000 mg/kg: Animals that died within 2 days: Heart: acute dilatation on the right; acute congestive hyperemia; adipose tissue/muscles: stained brown-yellow; intestine: single cases of a state indicative of preceding diarrhea. Animals that died within 4 days: intestine: dark brown contents; liver, kidneys, heart and lung: dark complexion, peritoneum and subcutis: stained brown-yellow. Animals that died within 6 days: cadaverous, probably overstaining of organs.3160 mg/kg: animals that died within 3 days: Heart: acute dilatation on the right; acute congestive hyperemia; adipose tissue/muscles: stained orange; animals that died within 6 days: conspicuously grey musculature; lung: wet, fleshy, hyperemia; liver: despite blood-filled conspicuous centrilobular pattern visible. Animals that died within 7 days: heart: dilatation of the ventricle; congestive hyperemia; muscles: despite cadaverous conditions grey-yellow staining observable.Sacrificed animals:5000 mg/kg: Kidneys: conspicuously dark.3160, 2150 and 1470 mg/kg: No abnormalities were observed.

Any other information on results incl. tables

Mortality:

 Dose: mg/kg  gender  1h  24h  48h  7 days  14 days
5000  Male  0/5    0/5    0/5  3/5  3/5
5000  Female  0/5    0/5   0/5  5/5  5/5
3160  Male  0/5    0/5    0/5  2/5  2/5
3160  Female 0/5    0/5     0/5  1/5  1/5
2150  Male 0/5     0/5    0/5    0/5    0/5
2150  Female 0/5     0/5    0/5    0/5    0/5
1470  Male  0/5    0/5    0/5    0/5    0/5
1470  Female  0/5    0/5    0/5  1/5  1/5

Weight in g (mean):

 Dose: mg/kg  gender  0 days  2 days  7 days  13 days  
 5000  Male  210  215  180  228  
5000  Female  160  162  -  -  
 3160  Male  210  218  184  249  
 3160 Female   180  180  162  208  
 2150  Male  210  208  234  268  
 2150  Female  180  173  185  217  
 1470  Male  170  195  216  253  
 1470  Female  180  176  191  213  

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The analogue substance 1 was tested for acute toxicity oral rats following a method similar to OECD401. Under the experimental conditions the substance showed LC50 ca 3800 mg/kg bw /day.
Executive summary:

The analogue substance 1 was tested for acute toxicity oral rats following a method similar to OECD401. The doses were 5000, 3160, 2150 and 1470 mg/kg bw /day by gavage for 5 animals/dose. Under the experimental conditions the substance showed LC50 ca 3800 mg/kg bw /day.