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Administrative data

Description of key information

Acute oral toxicity

Trigonox T (90 -92% tert-butyl cumyl peroxide) was administered by oral route (gavage at 3, 3.6, 4.32, 5.18, 6.22 ml/kg bw) to groups of 10 White Albino rats (5 males, 5 females) (Spanjers and Til, 1977). Animals were then observed for 14 days.3/10 animals died at the lowest dose exposure. 4/10 animals died at 3.6 and at 4.32 ml/kg doses. 5/10 animals died at 5.18 ml/kg and 6/10 animals died at the highest dose. Within one hour after treatment the rats showed sluggishness, decreased activity and slight tremors. After 24 hours wet coats developed in most of the rats and an occasional rat exhibited diarrhoea. Deaths occurred between 8 and 53 hours after dosing. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors revealed baldness of the urogenital region of several rats. At autopsy pale kidneys were seen in some of the males.Under these experimental conditions, the oral LD50 of the test item in rat is 5.18 ml/kg, equivalent to 4870 mg/kg.

 

Acute inhalation toxicity

The acute inhalation toxicity of Trigonox T (90 -92 % w/w of tert-butyl cumyl peroxide) was studied by exposing rats for four hours to an atmosphere containing 140 ppm of the test material, which was the highest concentration attainable (Reuzel and Hendriksma). No mortality occurred. Eye irritatioin and a decreased respiration frequency were observed. The 4-hour LC0 of Trigonox T in rats appeared to be higher than 140 ppm (1.2 mg/L).

 

Acute dermal toxicity in rats

Peroximon 801 (96.8% tert-butyl-cumyl peroxide) was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females), in a well conducted acute dermal toxicity test (OECD 402, GLP) (Manciaux, 1999a). The application was performed with the undiluted test substance at the dose of 2000 mg/kg. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance. All animals were subjected to necropsy. The general behaviour of the animals was not affected by treatment with the test substance. A reduced weight gain or slight bodyweight loss were observed in two females during the observation period. The overall body weight gain of the ether animals was not affected by treatment with the test substance. No cutaneous reactions were observed. No death occurred at 2000 mg/kg. No apparent abnormalities were observed at necropsy. The dermal LD0 of Peroximon 801 was equal to or higher than 2000 mg/kg bw in 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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Albino White
Sex:
male/female
Details on test animals and environmental conditions:
Prior to the study, The body weights of males varied from 235 to 354 g, those of females from 150 to 199 g.
The rats were housed in groups of five in screen-bottomed stainless steel cages in a well-ventilated room, maintained at 23-25°C.
Before dosing the rats were fasted overnight.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
3.0, 3.6, 4.32, 5.18, 6.22 ml/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation post-exposure: 14 days.
Autopsy was carried out on all survivors.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5.18 mL/kg bw
Based on:
test mat.
95% CL:
3.2 - 8.4
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 870 mg/kg bw
Based on:
test mat.
Remarks on result:
other: based on a density of 0.94
Mortality:
Deaths occurred between 8 and 53 hours after dosing. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period.
Clinical signs:
Within one hour after treatment the rats showed sluggishness, decreased activity and slight tremors.
After 24 hours wet coats developed in most of the rats and an occasional rat exhibited diarrhoea.
Gross pathology:
At autopsy pale kidneys were seen in some of the males.
Other findings:
Macroscopic examination of the survivors revealed baldness of the urogenital region of several rats.

Dose(ml/kg) males females Mortality (%)
3.00 2 1 30
3.60 2 2 40
4.32 1 3 40
5.18 2 3 50
6.22 2 4 60
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The oral LD 50 of tert buty cumyl peroxide is 5.18 ml/kg (4870 mg/kg) in rats.
Executive summary:

Trigonox T (90 -92% tert-butyl cumyl peroxide) was administered by oral route (gavage at 3, 3.6, 4.32, 5.18, 6.22 ml/kg bw) to groups of 10 White Albino rats (5 males, 5 females). Animals were then observed for 14 days. 3/10 animals died at the lowest dose exposure. 4/10 animals died at 3.6 and at 4.32 ml/kg doses. 5/10 animals died at 5.18 ml/kg and 6/10 animals died at the highest dose. Within one hour after treatment the rats showed sluggishness, decreased activity and slight tremors. After 24 hours wet coats developed in most of the rats and an occasional rat exhibited diarrhoea. Deaths occurred between 8 and 53 hours after dosing. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors revealed baldness of the urogenital region of several rats.At autopsy pale kidneys were seen in some of the males. Under these experimental conditions, the oral LD50 of the test item in rat is 5.18 ml/kg, equivalent to 4870 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 870 mg/kg bw
Quality of whole database:
Key study, Klimisch 2.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
The weight of the males ranged from 186-192g, that of the females from 136-144g.
The rats were obtained from the Central Institute for the Breeding of Laboratory Animais, TNO, Zeist, The Netherlands.
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: horizontally placed glass cylinder (0.90 x 0.15m) with sampling ports on both ends
- Exposure chamber volume: 0.135m3
- Method of holding animals in test chamber: stainless steel wire screens for the individual accommodation of the experimental animals.
- Source and rate of air: compresse air Iine, 1.0 L/min/evaporator
- Method of conditioning air: filtered air (relative humidity about 45%)
- System of generating vapors: 5 evaporator were laden with Chromosorb W-AW-60/80, saturated with Trigonox T. The temperature of the evaporators during the experiment was 22°C.
- Method of particle size determination: not relevant
- Treatment of exhaust air: no data
- Temperature in air chamber: 24°C

TEST ATMOSPHERE
- Brief description of analytical method used: Analysis of the peroxide was carried out gaschromatographically, using an "Intersmat" gas chromatograph with a FID (flame ionisation detector} and a stainless steel column (diemeter 6x 4mm; 0.30m) packed with QF-1 (14.8% diglycerol 0.13% on chromosorb G.AW-DMCS). Column -, injection- and detector-temperatures were 80, 95 and 100°C respectively. The gas-chromatograph was calibrated by injecting samples of a known solution of Trigonox T in ethanol.
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Analysis of the peroxide was carried out gaschromatographically,
Duration of exposure:
4 h
Concentrations:
140 ppm (1.2 mg/L)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
After exposure, the animals were returned to their living cages and provided with stock diet and tap water ad libitum for an observation period of 14 days.
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 1.2 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occured.
Clinical signs:
other: Eye irritation and a decreased respiration frequency were observed. During the first quarter of an hour of the exposure period, the rats were slightly restless and kept their eyes half-closed. For the remainder of the exposure period the rats were rather
Interpretation of results:
GHS criteria not met
Conclusions:
From the results of the present acute inhalation study it is concluded that the 4-hour LC0 of Terbutyl cumyl peroxide is higher than 140ppm (1.2mg/l).
Executive summary:

The acute inhalation toxicity of Trigonox T (90 -92 % w/w of tert-butyl a,a-dimethylbenzyl peroxide) was studied by exposing rats for four hours to an atmosphere containing 140 ppm of the test material, which was the highest concentration attainable. No mortality occurred. Eye irritatioin and a decreased respiration frequency were observed. The 4-hour LC0 of Trigonox T in rats appeared to be higher than 140 ppm (1.2 mg/L).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
1 200 mg/m³
Quality of whole database:
Key study, Klimisch 2.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals:
Species, strain: rat, Sprague-Dawley ICO: OFA-SD (IOPS Caw).
Reason for this choice: rodent species generally accepted by regulatory authorities for this type
of study.
Breeder: lffa Crédo, 69210 L'Arbresle, France.
Number and sex: one group of ten animals (five males and five females).
Age/weight: on the day of treatment, the animals were approximately 8 weeks old, and had a mean body weight ± standard deviation of 262 ± 15 g for the males and 235 ± 8 g for the females.
Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: the animals were identified individually by earmarks or earnotches.

Environmental conditions:
. temperature: 21 ± 2°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 hl12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording.
During the acclimatization period, one to seven animals of the same sex were housed in polycarbonate cages. During the treatment period, the animals were housed individually in polycarbonate cages.
Food and water ad libitum. No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.


Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On the day before treatment, the dorsal area (6 cm x 8 cm) of each animal was clipped using electric clippers. Only animais with healthy intact skin were used for the study.
The test substance was applied undiluted taking into consideration that its specific gravity was 0.932 g/ml. It was placed directly on an area of the skin representing approximately 10% (5 cm x 6 cm for the females and 5 cm x 7 cm for the males) of the body surface of the animals. A hydrophilic gauze pad was then applied to the skin. The test substance and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test substance by the animals. No residual test substance was observed at removal of the dressing. The dose applied to each animal was adjusted according to body weight determined on the day of treatment.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: historical laboratory controls
Details on study design:
Post observation period : 14 days.
The animals were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15.
The animals were weighed individually just before administration of the test substance on day 1 and the days 8 and 15.
On day 15, all animals were killed by carbon dioxide asphyxiation and a macroscopic examination was performed. (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities). In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality.
Clinical signs:
No clinical signs were observed.
Body weight:
A reduced weight gain or slight bodyweight loss were observed in two females during the observation period. The overall body weight gain of the other animals was not affected by treatment with the test substance.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD0 of the test substance tert-butyl-cumyl peroxide equal to or higher than 2000 mg/kg in rats.
Executive summary:

Peroximon 801 (96.8% tert-butyl-cumyl peroxide) was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females), in a well conducted acute dermal toxicity test (OECD 402, GLP). The application was performed with the undiluted test substance at the dose of 2000 mg/kg. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance.All animals were subjected to necropsy. The general behaviour of the animals was not affected by treatment with the test substance.

A reduced weight gain or slight bodyweight loss were observed in two females during the observation period. The overall body weight gain of the ether animals was not affected by treatment with the test substance. No cutaneous reactions were observed. No death occurred at 2000 mg/kg. No apparent abnormalities were observed at necropsy. The dermal LD0 of Peroximon 801 was equal to or higher than 2000 mg/kg bw in rats.


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Key study, Klimisch 1.

Additional information

Justification for classification or non-classification

According to EU Regulation (EC) N0. 1272/2008 (CLP), Tert-butyl-a,a-dimethylbenzyl peroxide (TBCP) is not classified for acute, oral, and inhalation toxicity.