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EC number: 223-356-0 | CAS number: 3851-87-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity was assessed in a non GLP study equivalent to OECD 401. Acute dermal toxicity was assessed in a GLP guideline study according to OECD 402yt
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Valid with restriction; meets generally accepted scientific standards, well documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TNO
- Age at study initiation: young adults
- Weight at study initiation: males: 182-322 g, females: 140-230 g
- Fasting period before study: overnight
- Housing: goups of 5
- Diet (e.g. ad libitum): after treatment ad libitum
- Water (e.g. ad libitum): after treatment ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 75% solution in isododecane
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 ml per kg bodyweight
- Doses:
- 11.6, 13.9, 16.7, and 20 ml per kg bodyweight
- 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: no data
- Necropsy of survivors performed: yes - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 12.7 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 9.3 - <= 17.3
- Mortality:
- Mortality of the doses tested: 40-90 % (see Table 1); most death occured between 17 hours and 6 days after treatment; two males died on day 8 and 9
- Clinical signs:
- other: sluggishness, humpback behaviour and severe diarrhoea; irritation of the skin in the area around anus and tailroot, encrustations around eyes and nostrils; at the end of the observation period some rats showed necrosis of the skin around anus and tailroot
- Gross pathology:
- no treatment-related gross alterations
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of bis-(3,5,5-trimethylhexanoyl)peroxide (75% in isododecane) was calculated to be 12.7 ml which equates to 11.96 g/kg bw.
- Executive summary:
In an acute oral toxicity study, groups of fasted, young adult Wistar derived male and female rats (5 per sex and dose) were given a single oral dose of bis-(3,5,5-trimethylhexanoyl)peroxide in 75% isododecane at doses of 11.6, 13.9, 16.7 and 20 ml/kg bw by gavage and were observed for 14 days. The LD50 was calculated to be 12.7 ml per kg body weight (which equates to 11.96 g/ kg bw) with 9.3 and 17.3 as the 95 % confidence limits.
Bis-3,5,5 -trimethylhexanoyl peroxide in 75% isododecane is practically non-toxic. This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study in the rat.
Reference
Table 1: Dosis applied and mortality observed
Dose ml/kg |
Mortality (No. of died per total animals per dose) |
|
|
males |
females |
% of mortality |
|
11.6 |
3/5 |
1/5 |
40 |
13.9 |
3/5 |
3/5 |
60 |
16.7 |
5/5 |
4/5 |
90 |
20 |
5/5 |
3/5 |
80 |
The LD50 was calculated according to the method of Weil (Biometrics 8 (1952) 249 -263).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-10-17 to 1995-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, 69210 L`Arbresle, France
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males 259 +/- 6 g, females 229 +/- 2 g
- Housing: during acclimatisation 4-7 of same sex; during treatment individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30-70 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the substance was administered in its original form
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 cm x 6 cm (females), 5 cm x 7 cm (males)
- % coverage: 10 %
- Type of wrap if used: hydrophilic gauze pad (Semes France)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.3 ml/kg
- Concentration (if solution): 99 % - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- 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: frequent observations during hours following administration; thereafter: at least once a day; weighing: before administration and on day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no statistics
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no death occured during obeservation period
- Clinical signs:
- other: no clinical signs and no cutaneous reactions during study
- Gross pathology:
- no apparent abnormalities
- Other findings:
- none
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions the dermal LD0 of the test substance bis-(3,5,5-trimethylhexanoyl)peroxide was higher than or equal to 2000 mg/kg in rats. No signs of toxicity were observed at this dose.
- Executive summary:
The acute dermal toxicity of bis-(3,5,5-trimethylhexanoyl) peroxide was assessed according to OECD guideline 402. The test substance was applied in its original form to the skin of one group of ten Sprague-Dawley rats (five males and five females) at a dose of 2000 mg/kg. The test site was covered by a semi-occlusive dressing for 24 h. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single administration of the test substance. All animals were subject to necroscopy. No cutaneous reactions were observed. The behaviour and body weight was not affected by the treatment. No deaths occurred at 2000 mg/kg. No abnormalities were observed at necroscopy.
Reference
Table 1: Individual and mean body weight and weekly body weight change of treated rats (g)
Dose (mg/kg) |
Volume (ml/kg) |
Sex |
Animals |
Day 1 |
Body weight gain |
Day 8 |
Body weight gain |
Day 15 |
2000 |
2.3 |
male |
1 |
264 |
42 |
306 |
71 |
377 |
|
|
|
2 |
258 |
31 |
289 |
55 |
344 |
|
|
|
3 |
265 |
51 |
316 |
76 |
392 |
|
|
|
4 |
257 |
56 |
313 |
54 |
367 |
|
|
|
5 |
251 |
50 |
301 |
53 |
354 |
|
|
|
M |
259 |
46 |
305 |
62 |
367 |
|
|
|
SD |
6 |
10 |
11 |
11 |
19 |
2000 |
2.3 |
female |
1 |
229 |
18 |
247 |
19 |
266 |
|
|
|
2 |
228 |
2 |
230 |
17 |
247 |
|
|
|
3 |
232 |
28 |
260 |
18 |
278 |
|
|
|
4 |
230 |
12 |
242 |
30 |
272 |
|
|
|
5 |
227 |
27 |
254 |
26 |
280 |
|
|
|
M |
229 |
17 |
247 |
22 |
269 |
|
|
|
SD |
2 |
11 |
12 |
6 |
13 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The LD50 of bis-(3,5,5-trimethylhexanoyl)peroxide (75% in isododecane) was calculated to be 12.7 ml which equates to 11.96 g/kg bw. The dermal LD50 of bis-(3,5,5-trimethylhexanoyl)peroxide is higher than or equal to 2000 mg/kg in rats. No signs of toxicity were observed at this dose.
Justification for selection of acute toxicity – oral endpoint
study is equivalent to a guideline study
Justification for selection of acute toxicity – dermal endpoint
GLP guideline study
Justification for classification or non-classification
LD50 values for oral and dermal acute toxicity were above the limit dose of 2000 mg/kg bw.
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