Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-110-7 | CAS number: 3006-82-4
- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- NA
- GLP compliance:
- not specified
Test material
- Reference substance name:
- tert-butyl 2-ethylperoxyhexanoate
- EC Number:
- 221-110-7
- EC Name:
- tert-butyl 2-ethylperoxyhexanoate
- Cas Number:
- 3006-82-4
- Molecular formula:
- C12H24O3
- IUPAC Name:
- tert-butyl 2-ethylhexaneperoxoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey
Housing: rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters
Conditioning period: 21 days prior to study initiation
Diet: ad libitum
Water: ad libitum
Body weights prior to administration: 2257 to 2817 g
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as the untreated control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- one application
- Observation period (in vivo):
- 24, 48, 72 hrs, 7 days
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
None of the rabbits received a washout
TOOL USED TO ASSESS SCORE: After grading the eye reaction, one drop of sodium fluorescein (at 72 hrs, 7 days) was instilled directly onto the corneal surface of each rabbit. After a few seconds, excess stain was flushed from the corneal surface with distilled water and the eyes examined with ultraviolet light.
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:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- 32829/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- 32841/M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- 32843/M
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #4
- Remarks:
- 32732/F
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #5
- Remarks:
- 32834/F
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #6
- Remarks:
- 32840/F
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- animal #1
- Remarks:
- 32829/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 32841/M
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 32843/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- 32732/F
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- 32834/F
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- 32840/F
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Other effects:
- NA
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the data obtained and in accordance with OECD GHS (1272/2008) the test material is evaluated as not irritating to eyes.
- Executive summary:
Tert.-Butylperoxy- 2-ethylhexanoat was tested in three male and 3 female New Zealand White rabbits similar to OECD guideline 405. Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2 % sodium solution. Rabbits exhibiting corneal lesions were discarded. The rabbits received 0.1 mL of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. The treated eyes were examined in accordance with the following schedule: 24 hrs following instillation, 48 hrs, 72 hrs and 7 days. After grading the eye reaction, one drop of sodium fluorescein (at 72 hrs, 7 days) was instilled directly onto the corneal surface of each rabbit. After a few seconds, excess stain was flushed from the corneal surface with distilled water and the eyes examined with ultraviolet light. Based on the data obtained and in accordance with OECD GHS (1272/2008) the test material would not be considered a primary eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
