Registration Dossier

Administrative data

Description of key information

In an acute oral toxicity study according to OECD TG 401 the LD50 value was determined to be above 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
The available study is considered reliable without restrictions.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

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 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. Besides piloerection in all animals on the day of dosing, all animals were overtly normal on the following day; none died; necropsy revealed no significant macroscopic lesion.

The LD50 value is determined to be > 2000 mg/kg bw.

 

Inhalation:

No acute inhalation study with the test substance is available.

Due to the solid properties of the test substance, exposure to vapour is considered negligible. In addition, experimental data on acute oral toxicity revealed no test substance related effects. Further, no skin and eye irritation potential was evaluated in the available in vivo studies and therefore no respiratory irritation is expected.

 

Dermal:

No acute dermal study with the test substance is available.

Numerous organic peroxides have been tested in acute dermal toxicity tests (41 organic peroxides covering all chemical subgroups/families of organic peroxides, excluding hydroperoxides). Experimental data of all of these organic peroxides, (except hydroperoxides), show no toxic effects at dermal application up to the tested concentration limit of 2000 mg/kg bw and show for this reason an acute dermal toxicity of >2000 mg/kg bw. Dermal peentration of the test item is further expected to be very low based on its physico-chemical properties. Therefore, a weight of evidence approach is scientifically applicable for chemically comparable organic peroxides and allows one to conclude also a dermal LD50 > 2000 mg/kg bw for the untested organic peroxide.

Justification for classification or non-classification

Based on the available data the test substance is not classified and labelled for acute oral, dermal and inhalation toxicity according to Regulation (EC) No 1272/2008 (CLP).