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Administrative data

Description of key information

The acute oral toxicity of diisobutyryl peroxide 30% was determined in rats. The test substance was given to groups of 5 males and 5 females in one single dose of 2000 mg per kg body weight. At 1 hour after treatment all animals showed moderate signs of sluggishness and piloerection. At 4 hours after treatment all animals showed moderate signs of diarrhoea. Signs of sluggishness and piloerection were not observed 4 hours after treatment. Signs of diarrhoea were not observed 24 hours after treatment. All animals gained weight after 3 days and thereafter, and no mortality occurred, however in most females a growth delay was observed. In most female animals a comparatively small stomach was observed at macroscopic examination at the end of the observation period, the other animals did not reveal any treatment-related gross alteration. The oral LD50 of the test substance was found to exceed 2000 mg per kg body weight, both in male and female rats.

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:
October 20, 1989 - November 3, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performe according to OECD guideline and GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River wiga GmbH, Sulzfeld, F .R. Germany.
- Age at study initiation: ± 5 weeks
- Weight at study initiation: 209 to 230 g for males and from 143 to 159 g for females.
- Fasting period before study: overnight
- Housing: The rats were housed in groups of five animals, males and females separated. They were kept under conventional conditions in stainless cages with wire-screen bottom.
- Diet (e.g. ad libitum): ad libitum, cereal-based, open-formula basal diet
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: October 20, 1989 - November 3, 1989
Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10.0 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 10.0 ml/kg
Doses:
2000 mg/kg bw
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: The rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and later on, at least once daily, throughout an observation period of 14 days. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalityoccurred.
Clinical signs:
At 1 hour after treatment all animals showed moderate signs of sluggishness and piloerection. At 4 hours after treatment all animals showed moderate signs of diarrhoea. Signs of sluggishness and piloerection were not observed 4 hours after treatment. Signs of diarrhoea were not observed 24 hours after treatment.
Body weight:
All animals gained weight after 3 days and thereafter however in most females a growth delay was observed.
Gross pathology:
In most female animals a comparatively small stomach was observed at macroscopic examination at the end of the observation period, the other animals did not reveal any treatment-related gross alteration.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 exceeds 2000 mg per kg body weight, both in male and female rats.
Executive summary:

The acute oral toxicity of diisobutyryl peroxide, 30% in phlegmatizer, was determined in rats. The test substance was given to groups of 5 males and 5 females in one single dose of 2000 mg per kg body weight. At 1 hour after treatment all animals showed moderate signs of sluggishness and piloerection. At 4 hours after treatment all animals showed moderate signs of diarrhoea. Signs of sluggishness and piloerection were not observed 4 hours after treatment. Signs of diarrhoea were not observed 24 hours after treatment. All animals gained weight after 3 days and thereafter, and no mortality occurred, however in most females a growth delay was observed. In most female animals a comparatively small stomach was observed at macroscopic examination at the end of the observation period, the other animals did not reveal any treatment-related gross alteration. The oral LD50 of the test substance was found to exceed 2000 mg per kg body weight, both in male and female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
This is the only acute toxicity study for this substance. It is an apparently well conducted GLP study conducted in accordance with OECD 401 and rated reliable without restrictions.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The registered substance, 30% in phlagmatizer, was not acutely toxic to rats when tested by the oral gavage route. Ingestion by humans is unlikely but if it does occur, irritation to the GI tract may result due to the corrosive nature of this substance.

Justification for selection of acute toxicity – oral endpoint

This is the only acute toxicity study for this substance.  It is an apparently well conducted GLP study conducted in accordance with OECD 401.

Justification for selection of acute toxicity – inhalation endpoint

In accordance with column 2 of REACH Annex VIII, the test for acute inhalation toxicity (required in section 8.5) does not need to be conducted as the substance is classified as corrosive to the skin (see IUCLID section 7.3).

Justification for selection of acute toxicity – dermal endpoint

In accordance with column 2 of REACH Annex VIII, the test for acute dermal toxicity (required in section 8.5) does not need to be conducted as the substance is classified as corrosive to the skin (see IUCLID section 7.3). In an acute dermal toxicity test most likely local irritation/corrosion causing secondary systemic toxic effects rather than substance related systemic toxicity would be detected.  Thus, a new test for acute dermal toxicity should not be conducted due to animal welfare reasons

Justification for classification or non-classification

Based on the results of the acute oral toxicity study, the data is conclusive but not sufficient for classification.