Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-07-21 to 1992-10-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
84/449/EEC
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River limited, Margate, Kent, England
- Age at study initiation: young adult
- Weight at study initiation: males: 112 - 123 g; females: 113 - 127 g
- Fasting period before study: overnight
- Housing: stainless steel grid cages
- Diet: commercially-available complete pelleted rodent diet was fed without restriction, except for removal of food for approximately 19 hours before aministration of the test material
- Water: free access to tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 21 °C
- Humidity: 38 - 57 %
- Air changes: 15 complete air changes per hour without re-cicrulation
- Photoperiod: lighting cycle of 12 hours of artificial

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 % w/v
- Amount of vehicle: 20 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: on the day before dosing and on Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No rat died.
Clinical signs:
Signs of reaction to treatment were confined to piloerection in all animals on the day of dosing. The animals were overtly normal on the following day.
Gross pathology:
All animals were killed at termination of the study. Each animal was thoroughly examined for abnormality of tissues or organs.
All body cavities were opened, larger organs were selectioned and the gastro-intestinal tract was opened at intervals for examination of the mucosal surfaces. All abnormalities were described or the normal appearance of major organs was confirmed.
No tissues were retained in fixative.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.
Executive summary:

The acute oral toxicity of ditetradecyl peroxydicarbonate was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg according to OECD guideline 401 and EU method B.1. The animals were starved overnight prior to dosing and the test material was administered at a constant volume-dosage of 20 mL/kg in aqueous 0.5 % w/v methylcellulose.

Mortality and sings of reaction to treatment were recorded during a subsequent 14 -day observation period. The animals were killed on the following day and subjected to necropsy.

There was no death. Signs of reaction to treatment were confined to piloerection in all animals on the day of dosing. The animals were overtly normal on the following day. The animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. The acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.