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EC number: 236-050-7 | CAS number: 13122-18-4
- 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
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- Nanomaterial radical formation potential
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- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- tert-butyl 3,5,5-trimethylperoxyhexanoate
- EC Number:
- 236-050-7
- EC Name:
- tert-butyl 3,5,5-trimethylperoxyhexanoate
- Cas Number:
- 13122-18-4
- Molecular formula:
- C13H26O3
- IUPAC Name:
- tert-butyl 3,5,5-trimethylhexaneperoxoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Housing: The animals are caged individually and receive no hay or other extraneous material that might enter the eyes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: One tenth of a mL of the test substance is allowed to fall on the averted lower lid of one eye of each rabbit. - Duration of treatment / exposure:
- one application
- Observation period (in vivo):
- 24, 48, 72 hours and 7 days after installation of the test material
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The eyes are not washed following installation and the animals are released immediately.
SCORING SYSTEM: The response is positive if, at any of the readings, discernable opacity of the cornea (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a deepening of the folds (rugae) or a slight circumcorneal injection), or if such substances produce in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with partial reversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernable. The FDA-scoring scale was used. The test is considered positive if four or more of the animals in the test group of six rabbits exhibit a positive reaction. If one animal exhibits a positive reaction, the test is regarded as negative.
TOOL USED TO ASSESS SCORE: Ocular reactions are read using a binocular magnifying glass. The diagnosis of corneal damage is confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes are examined in a dark room under ultraviolet illumination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Other effects:
- The ocular effects Trigonox 42 S were as follows:
slight redness of the conjunctivae in one out of six rabbits
Any other information on results incl. tables
Individual scores awarded to the ocular lesions elicited by Trigonox 42 S:
rabbit |
cornea |
iris |
conjunctivae |
|
redness |
chemosis |
|||
after 24 hours |
||||
9 |
0 |
0 |
1 |
0 |
10 |
0 |
0 |
0 |
0 |
11 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
after 48 hours |
||||
9 |
0 |
0 |
1 |
0 |
10 |
0 |
0 |
0 |
0 |
11 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
after 72 hours |
||||
9 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
11 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The present eye irritation test showed that, according to the FDA-standards, tert-Butylperoxy-3,5,5-trimethylhexanoat is not considered to be eye irritant.
- Executive summary:
Tert-Butylperoxy-3,5,5-trimethylhexanoat was tested to six New Zealand White albino rabbits. In general the techniques of tests as published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelly (Drug Cosmet. Industr. 71 (1952) 36) for eye irritation test are followed.
Six New Zealand White albino rabbits are used. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes. One tenth of a mL of the test substance is allowed to fall on the averted lower lid of one eye of each rabbit; the upper and lower eye lid is then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, served as a control. The eyes are examined at 24, 48, 72 hours and 7 days after installation of the test material.
Tert-Butylperoxy-3,5,5-trimethylhexanoat caused minimal lesions in one out of six rabbits. The present eye irritation test showed that, according to the FDA-standards, tert-Butylperoxy-3,5,5-trimethylhexanoat is not considered to be eye irritant.
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