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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
5/rat/sex; limit test; 14-days observation period
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 15 g in 50 ml

MAXIMUM DOSE VOLUME APPLIED: 16.7 ml / kg

Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: day 0, day 7, day 14

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Body weight:
Weight in g
male day 0 day 7 day 14
1 160 210 255
2 135 180 235
3 155 200 240
4 165 210 260
5 155 200 240
female
6 160 180 205
7 160 170 185
8 155 170 185
9 155 165 190
10 150 165 180

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 > 5000 mg/kg
Executive summary:

Method

5 rat/sex were dosed by oral route at 5000 mg/kg as single dose. Observations were carried out for 14 days after dosing.

Results

No mortality was recorded. LD50 > 5000 mg/kg.