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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 10, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

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:
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 material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation:6 weeks
- Weight at study initiation:average body weight of 170 g (male) and 145 g (female)
- Fasting period before study:
- Housing:Rats were caged singly and kept in a room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Photoperiod (hrs dark / hrs light):12 hours artificial light and 12 hours darkness in each 24 hour period

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
tap water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % w/v

MAXIMUM DOSE VOLUME APPLIED:20 ml/kg (equivalent to 5 g/kg of compound)
Doses:
20 ml/kg (equivalent to 5000 mg/kg bw)
No. of animals per sex per dose:
Ten rats (5 males and 5 females)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the 14 day observation period.
Clinical signs:
No clinical symptoms were recorded during the 14 day observation period.
Gross pathology:
At autopsy 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: CLP criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

Method

The compound was tested on 10 healthy Sprague-Dawley rats (5 males/ 5 females), aged 6 weeks having average body weight of 170g (male) and 145 g (female). Rats were caged singly and kept in a room maintained at a temperature of 21 °C with 12 hour light/dark period.

A 25 % w/v suspension of the compound in tap-water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20 ml/kg (equivalent to 5000 mg/kg bw).

Observation

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. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Conclusion

The acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw. The compound has therefore is not considered to cause acute toxicity to the rat by this route of administration.