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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
Study period:
1979-03-14 to 1979-04-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study performed according to a method equivalent to OECD Guideline 401. Limited information was reported on test conditions, however sufficient animals were tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

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
Type:
Constituent
Test material form:
liquid
Details on test material:
Details described in study specific records
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4236-21-35
- Substance type: Clear colourless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Mass.
- Age at study initiation:
- Weight at study initiation: 220 to 314 grams
- Fasting period before study: approximately seventeen hours prior to administration of test material
- Housing: Following dosing, the rats were individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was administered by oral intubation in the form received. The dose levels were calculated according to the density provided by the sponsor as being 0.944 g/mL.
Doses:
The animals were dosed at the following dose levels: 1000, 1400, 2000, 2800 and 4000 mg/kg.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded prior to fasting, at day 7 and at the termination of the study (day 14)
- Necropsy of survivors performed: yes: A gross necropsy was performed on all animals at the time of death or terminal sacrifice (day 14).
- Observations for mortality and overt signs of effect were made at 0-2 hours and at 4-6 hours following dosing and daily thereafter for fourteen days.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 200 mg/kg bw
Based on:
test mat.
95% CL:
1 900 - 2 500
Mortality:
1000 mg/kg: 1/10 animals died
1400 mg/kg: 0/10 animals died
2000 mg/kg: 2/10 animals died
2800 mg/kg: 9/10 animals died
4000 mg/kg: 10/10 animals died
Clinical signs:
Piloerection was noted at all levels throughout the observation period in the majority of the surviving animals. Motor activity decrease was evident at all levels most notably within twenty-four hours following test material administration. Also noted within the twenty-four hour period following intubation were red nasal and oral discharges and resipratory rate decrease. These signs were evident mainly at the 1000, 1400 and 2000 mg/kg dose levels.
Body weight:
All surviving animals at all dose levels exhibited weight gains during the fourteen-day post-dose observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
The oral LD50 for this substance is 2200 mg/kg with 95% confidence limits of 1900 to 2500 mg/kg. Based on this result, the test substance is not to be classified according to the CLP Regulation.