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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:
weight of evidence
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(only basic information given)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: Tylers Original
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 20 ± 2
- Fasting period before study: overnight
- Housing: in solid floor polycarbonate boxes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL solution
Doses:
500, 1000, 1500, 2000 and 2500 mg/kg bw (and also 5000 mg/kg bw in the preliminary study).
No. of animals per sex per dose:
2 in preliminary study
10 in main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily

Results and discussion

Preliminary study:
A rangefinding trial was performed with 2 animals per dose (500, 1000, 2500 and 5000 mg/kg bw)
500 and 1000 mg/kg bw: no deaths occured
2500 mg/kg bw and more: all animals died on Day 1
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 175 mg/kg bw
Based on:
test mat.
95% CL:
>= 987 - <= 1 410
Mortality:
For details refer to Table 1 under "any other information on results".
Clinical signs:
500 mg/kg bw and more: convulsions and stretching within 90 min of dosing, symptoms less severe in survivors after 48 h, asymptomatic after 72 h

Any other information on results incl. tables

Table 1 Acute oral toxicity: main study data for Day 14 only

Dose Mortality on Day 14
[mg/kg bw]
  N*
Males/Females
500 0/10
1000 6/10
1500 8/10
2000 9/10
2500 10/10

Table 2 Acute oral toxicity in the mouse: combined preliminary and main study data

 Dose mg/kg bw  Mortality on Day 4 (No.)
 500 0/12
 1000  6/12
 1500  6/12
 2000  8/10
 2500  11/12

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 = 1175 mg/kg bw.
Executive summary:

The LD50 in the mouse was 1175 mg/kg bw.