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Toxicological information

Acute Toxicity: oral

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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:
other: The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure period 7 days [but no later deaths expected]; no data about body weight)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Body weight at initiation: 176 - 294 g (range)
No further details.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Application of up to 40% aqueous solution; no data about fasting prior to application. Vehicle: Doubly distilled water.
Doses:
The doses above were administered as aqueous solution of 2% (200 µl/kg bw), 20% (1600 µl/kg bw), 30% (3200 and 6400 µl/kg bw) and 40% (8000 and 10000 µI/kg bw) test substance in water, respectively.
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
Group-wise documentation of clinical signs was performed over the 7- 8-day study period. Body weight was determined before the start of the study for determination of dose.
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.
Statistics:
LD50 estimated

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 10 mL/kg bw
Remarks on result:
other: LD50 for males and females combined
Mortality:
200, 1,600, and 3,200 µI/kg bw: no deaths
6400 µI/kg bw: 1 male died within 4 days, 1 female died within the first 24 hours and another female died within 6 days
8000 µI/kg bw: no males died, 3 females died within the first 48 hours
10000 µI/kg bw: no males died, all females died within the first 24 hours
Clinical signs:
10000 and 8000 µI/kg bw: staggering, dyspnoea immediately after application, exophthalmus, slight peripheral hyperemia, reddish eyes, reduced attention, polyuria, motor excitation, squatting posture, piloerection, eyelid closure and crusts until including study day 5. No clinical signs and findings in the surviving animals from the sixth post observation day onward.
6400 µI/kg bw: staggering, dyspnoea immediately after application, exophthalmus, abdominal and lateral position, apathy, dyspnoea, reduced attention, piloerection, slight reddish eyes, rolling convulsions (only one animal) until including study day 7. No clinical signs and findings in the surviving animals from the eighth post observation day onward.
3200 µI/kg bw: staggering, dyspnoea immediately after application, exophthalmus, reduced attention, piloerection and slight reddish eyes until including study day 7 . No clinical signs and findings in the surviving animals from the eighth post observation day onward.
1600 and 200 µl/kg bw: staggering after application on day O. No clinical signs and findings from the first post observation day onward.
Body weight:
no data
Gross pathology:
Animals that died after 10000, 8000 and 6400 µI/kg bw: hemorrhage in the pancreas, soft feces, dark urine or no abnormalities.
Animals examined at termination of the study at 6400, 3200, 1600 and 200 µI/kg bw: Organs without particular findings (no data about males in the high dose group).
Other findings:
no data

Any other information on results incl. tables

No estimation of LD50 only for males.

Applicant's summary and conclusion

Conclusions:
In male and female rats combined the oral LD50 is appr. 10000 µl/kg bw corresponding to 11800 mg/kg bw.
Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure period 7 days [but no later deaths expected]; no data about body weight).

Groups of 5 male and 5 female rats were gavaged with 2 - 40% aqueous solutions at dose levels of 200, 1600, 3200, 6400, 8000, and 10000 µl/kg bw. The post exposure observation period was 7 days. Clinical signs like staggering, dyspnoea immediately after application, exophthalmus, slight peripheral hyperemia, reddish eyes, reduced attention, polyuria, motor excitation, squatting posture, piloerection, and eyelid closure occurred and were reversible at the end of the post exposure observation period. Mortality was evident at >= 6400 µl/kg bw. Females were more sensitive than males. Necropsy revealed several rats with pancreas bleeding.

Conclusion: In male and female rats combined the oral LD50 is appr. 10000 µl/kg bw corresponding to 11800 mg/kg bw.