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: 222-340-0 | CAS number: 3437-84-1
- 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:
- August 14, 1989 - August 28, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performe according to OECD guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bisisobutyryl peroxide
- EC Number:
- 222-340-0
- EC Name:
- Bisisobutyryl peroxide
- Cas Number:
- 3437-84-1
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 2-methylpropanoyl 2-methylpropaneperoxoate
- Details on test material:
- Appearance:a clear, slightly viscous liquid
Batch No: 130789
Subsatnce ID: "Trigonox 187-C30, ex ch 130789""
Chemical name: Diisobutyrylperoxide.
Active ingredient and purity: diisobutyrylperoxide 30%
Trade name: Trigonox 187-C30,
cas Reg. no.: 3437-84-1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2604 g
- Housing: The animal was housed in a suspended, galvanized cage, fitted with a wire-mesh floor and front
- Diet (e.g. ad libitum): standard laboratory rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): at least 40%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): natural day/night cycle
IN-LIFE DATES: August 14, 1989 - August 28, 1989
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remaining untreated, served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- Ocular reactions were judged at circa one hour, at circa 24, 48, 72 hours, and at 8, and 14 days after treatment
- Number of animals or in vitro replicates:
- 1, 1, the effects were of a very severe degree. Therefore, it was decided not to continue the study with another two rabbits.
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: ischemic necrosis of the conjunctivae
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: ocular discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14-days
- Irritant / corrosive response data:
- Approximately one minute after treatment the animal began to scream for about one minute. This screaming is considered to be a clear sign of pain due to treatment with the test substance.
At one hour after treatment, the eye effects observed consisted of moderate redness of the conjunctivae, severe swelling of the conjunctivae. In addition, moderate ocular discharge was observed. At 24 hours after treatment, the eye effects observed consisted of slight corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge. At 48 and 72 hours after treatment, the eye effects observed consisted of moderate corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge. During the following five days, the eye effects partly cleared. At 8 days after treatment, the eye effects observed consisted of slight corneal opacity, slight redness of the conjunctivae, slight swelling of the conjunctivae, and slight ocular discharge. At 14 days after treatment, the eye effects had cleared completely.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The results for 30% diisobutyryl peroxide in a solvent would result in a classification as irritating to the eyes.
- Executive summary:
A 30% dilution of diisobutyIyl peroxide was examined for acute eye irritating/corrosive properties in an experiment with one albino rabbit.
The test substance caused moderate corneal opacity, slight iritis, severe redness of the conjunctivae, severe swelling of the conjunctivae, ischemic necrosis of the conjunctivae, and severe ocular discharge.
At 14 days after treatment, the eye effects had cleared completely. Because of the severe degree of the effects observed and for ethical
reasons, it was decided to use for this study only one animal instead of three.
On thee basis of the results obtained it was concluded that, under the conditions of this study, a 30% dilution of diisobutyIyl peroxide is irritating, but not corrosive to eyes.
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.
