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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
September 11, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
Similar substance 1
IUPAC Name:
Similar substance 1
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 170 g. (♂), and 145 g. (♀).
- Fasting period before study: 18 hours
- Housing: Rats were caged singly
- Diet: commercial pelleted diet (Oakes Special Diet with added vitamin E) was fed ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2 °C
- Humidity (%): ~50 %
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % in water

Doses:
5000 mg/kg b.w
No. of animals per sex per dose:
5 x sex x dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 345 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
not found
Clinical signs:
No clinical symptoms were recorded
Gross pathology:
no changes in organs or tissues caused by the administration of the test compound were seen.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
The acute oral median lethal dose (LD50) of test item in rats is greater than 5000 mg/kg b.w (4345 based on active ingr.)
Executive summary:

The substance was tested for acute toxicity by oral route. The compound was tested on 10 healthy Sprague-Dawley derived rats, males and females were segregated individually in a room kept at a constant temperature. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

The acute oral median lethal dose (LD50) of test item in rats is greater than 5000 mg/kg b.w (4345 based on active ingr.)