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EC number: 229-782-3 | CAS number: 6731-36-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-03-31 to 2010-09-14
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
- EC Number:
- 229-782-3
- EC Name:
- Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide
- Cas Number:
- 6731-36-8
- Molecular formula:
- C17H34O4
- IUPAC Name:
- 1,1-bis(tert-butylperoxy)-3,3,5-trimethylcyclohexane
- Details on test material:
- Identification: Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8)
REACH Name: Trigonox® 29
Description: Colorless liquid
Batch Number: 0905137109
Purity: 98.16 %
Expiry Date: 13-May-2010
Stability of Test Item: Stable under storage conditions.
Storage Conditions: In freezer (range of -20 ± 5 °C, provided by Harlan Laboratories Ltd.), kept in original container, stored separate from other chemicals, away from sources of heat and sunlight. Shock and friction was avoided.
Safety Precautions: A helmet mask was worn during manipulations with the test item. Otherwise, routine hygienic procedures were used to ensure the health and safety of the personnel.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animals:
Animals: Young Adult New Zealand White Rabbit, SPF
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Charles River Laboratories France, BP 0109, 69592 L’Arbresle / France
Number of Animals per Test: 3 (Animals of both sexes were used)
Age (when treated): 14 weeks (male No. 70), 18 weeks (female No. 71), 20 weeks (female No. 72)
Body Weight Range (when treated): 3137 g (male No. 70), 2827 g (female No. 71), 2814 g (female No. 72)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Environmental Conditions:
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with a room temperature of 17-23 °C and a relative humidity between 30-70%, automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
Diet: Pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10) provided by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) available ad libitum. Results of analyses for contaminants are archived at Harlan Laboratories Ltd. A piece of wood (imported by Indulab AG, Gams / Switzerland from ABEDD® - LAB & VET GmbH, 1160 Vienna / Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) were also provided for environmental enrichment.
Water: Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at Harlan Laboratories Ltd.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) was withdrawn with a syringe and applied undiluted. The test item was applied at 0.1 mL/animal, the dose specified in the test guidelines for a liquid test item.
- Duration of treatment / exposure:
- Single exposure.
- Observation period (in vivo):
- 7 (animal no. 70 and 72) or 10 days (animal no. 71), respectively
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) was used as delivered by the Sponsor.
The pH of the test item was measured from an aliquot of the test item, before the study initiation date. By using pH strips, the pH was found to be 4-5.
According to Commission Regulation (EC) No 440/2008 B.5. and OECD Guidelines 405, a test item is not required to be tested if the pH-value is less than 2 or greater than 11.5, owing to its predictable corrosive properties.
The eyes of the animals were examined one day prior to test item administration.
0.1 mL of di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) was withdrawn with a syringe and applied undiluted. The test item was applied at 0.1 mL/animal, the dose specified in the test guidelines for a liquid test item.
The test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control.
A single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1- and 24-hour examinations, the test was completed using the two remaining animals.
Rationale: The application form and dose were used to detect an irritating potential of the test item applied.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0.67
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The instillation of di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) into the eye resulted in mild, early-onset and transient ocular changes, such as slight to moderate reddening of the conjunctivae and slight to moderate reddening of the sclerae. Also, slight swelling of the conjunctivae and slight ocular discharge was noted, although exclusively 1 hour after instillation. All effects were reversible and were no longer evident 7 days after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.
- Other effects:
- Coloration: No staining produced by the test item was observed in the treated eyes.
Corrosion:No corrosion of the cornea was observed at any of the reading times.
Any other information on results incl. tables
Viability / Mortality: No intercurrent deaths occurred during the course of the study.
Clinical Signs: No clinical signs were recorded throughout the entire observation period.
Body Weights: The body weight of the animals was within the range commonly recorded for this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria (Regulation (EC) No 1272/2008), di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) is not classified with respect to eye irritation in rabbits.
- Executive summary:
The primary eye irritation potential of di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7 days (all animals) or 10 days (just one animal) after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris light reflex and redness and chemosis of the conjunctivae. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 0.67 and 0.00 for reddening and 0.00, 0.00 and 0.00 for chemosis, respectively.
The instillation of di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) into the eye resulted in mild, early-onset and transient ocular changes, such as reddening and swelling of the conjunctivae, ocular discharge and reddening of the sclerae. These effects were reversible and were no longer evident 7 days after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
Based upon the referred classification criteria (Regulation (EC) No 1272/2008), di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) is not classified with respect to eye irritation in rabbits.
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