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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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
White crystalline powder
Perkadox 24
di-cetyl peroxydicarbonate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIVO-TNO
- Age at study initiation: Young
- Weight at study initiation: males 221 to 287 g and females 147 to 180 g
- Fasting period before study: overnight
- Housing: groups of five in screen-bottomed stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): no data
- Air changes (per hr): no data, a well-ventilated room
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Shellsol T
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (w/v) suspension
- Amount of vehicle (if gavage): 50%

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: None
- Necropsy of survivors performed: yes
:
Statistics:
None

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.
Clinical signs:
None of the rats showed any reaction upon the treatment. At the end of the observation period all treated animals looked quite healthy.
Body weight:
No data.
Gross pathology:
Macroscopic examination of the surviving rats revealed no treatment-related gross alterations.
Other findings:
No data.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 ≥ 5000 mg/kg bw
Executive summary:

10 male and 10 female were administered a 50 %{w/v} suspension of the test substance in Shellsol T.

None of the rats showed any reaction upon the treatment and no deaths occurred. At the end of the observation period all treated animals looked quite healthy. Macroscopic examination of the surviving rats revealed no treatment-related gross alterations

From the results it appeared that the LD50 is higher than 5 g/kg body weight.