Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 217-691-1 | CAS number: 1931-62-0
- 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:
- 1993-01-18 to 1993-05-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Version 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 84/449/EEC
- Version / remarks:
- EEC Publication No. L. 251, September 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- OO-tert-butyl monoperoxymaleate
- EC Number:
- 217-691-1
- EC Name:
- OO-tert-butyl monoperoxymaleate
- Cas Number:
- 1931-62-0
- Molecular formula:
- C8H12O5
- IUPAC Name:
- (2Z)-4-(tert-butylperoxy)-4-oxobut-2-enoic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- SOURCE OF TEST MATERIAL
- CAS No.: 1931-62-0
- Bulk Density: 0.48 g/ml
- Source and lot/batch No.of test material: 221190 ex PDD
- Expiration date of the lot/batch: 1993-07-01
- Purity test date: 1993-01-18
- Purity: approx. 98%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in refrigerator in the dark
- Stability under test conditions: stable
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the powdery test substance was instilled as delivered by the sponsor
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF Quality
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 13 weeks
- Weight at study initiation: 2419 - 2732 grams
- Housing: Individually labelled cages with perforated floors and equipped with an automatic drinking system. Standard laboratory conditions
- Diet (e.g. ad libitum): standard laboratory rabbit diet (LKK-20 pellet diameter 4 mm)
- Water (e.g. ad libitum): free access to tap-water diluted with decalcified water
- Acclimation period: 14 days before start of treatment under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 48 mg - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in day 2 after fluorescein examination, both eyes of all three animals were rinsed with approx. 50 ml tap-water per eye, using a velocity of flow which did not affect the eyes, to remove residual test substance.
SCORING SYSTEM: Scoring system for ocular lesions see chapter "Any other information on materials and methods"
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 21 d
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 21 d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Corneal opacity, varying from grade 1-3, was observed in animals 2 and 3 during the study, which persisted up to termination of the study {day 22). From day 15 onwards pannus formation (neovascularisation of the cornea) was seen in these two animals. In animal 1 slight dulling of normal lustre of the cornea was observed from day 2 until day 8. Treatment of the eyes with 2% fluorescein, 24 hours after instillation, revealed corneal epithelial damage in all animals. At following treatments with fluorescein, signs of recovery were noted in all animals and the corneal epithelial damage had completely resolved within 14 days after instillation in animal 1. In animals 2 and 3 the epithelial damage had not resolved on day 22.
The iridic irritation had resolved within 7 days after instillation in all three animals.
Moderate to severe irritation of the conjunctivae was observed in all animals over the first week. Recovery was noted from day 15 onwards, but the irritation had not completely resolved at day 22. Reduced elasticity of the eyelids, a reduction of the size of the pupil in the treated eye and/or gray/white discoloration of the conjunctivae, as a sign of necrosis, were observed in animals 2 and 3 during the study.
For more detailed information on the individual response please see Table 2 in "Any other information on results. - Other effects:
- After the 24 hour observation the eyes were rinsed with water to remove remnants of the test substance. However the test substance could only be partly removed, which might have influenced further effects.
No systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 2: Individual Irritation Scores
Animal No. 1 | Eye Irritation Scores Post-Application after | ||||
Observation | 24 h | 48 h | 72 h | average score (24, 48 and 72 h) | 21 days after administration |
Cornea - opacity | 0 | 0 | 0 | 0,0 | 0 |
Iris | 1 | 1 | 1 | 1,0 | 0 |
Conjunctivae redness | 2 | 3 | 3 | 2,7 | 1 |
Conjunctivae chemosis | 4 | 3 | 3 | 3,3 | 0 |
Animal No. 2 | Eye Irritation Scores Post-Application after | ||||
Observation | 24 h | 48 h | 72 h | average score (24, 48 and 72 h) | 21 days after administration |
Cornea - opacity | 2 | 2 | 2 | 2,0 | 2 |
Iris | 1 | 1 | 1 | 1,0 | 0 |
Conjunctivae redness | 3 | 3 | 3 | 3,0 | 1 |
Conjunctivae chemosis | 3 | 2 | 2 | 2,3 | 0 |
Animal No. 3 | Eye Irritation Scores Post-Application after | ||||
Observation | 24 h | 48 h | 72 h | average score (24, 48 and 72 h) | 21 days after administration |
Cornea - opacity | 2 | 1 | 1 | 1,3 | 2 |
Iris | 1 | 1 | 1 | 1,0 | 0 |
Conjunctivae redness | 3 | 3 | 3 | 3,0 | 1 |
Conjunctivae chemosis | 3 | 2 | 2 | 2,3 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In an in vivo acute eye irritation/corrosion study in rabbits according to OECD 405, OO-tert-butyl monoperoxymaleate produced corrosive effects.
- Executive summary:
In a primary eye irritation study according to OECD 405, 48 mg of OO-tert-butyl monoperoxymaleate (98% purity) was instilled into the conjunctival sac of one eye of three male New Zealand White Rabbits (13 weeks old) for 24 h. Both eyes were washed with tap-water after 24 h of exposure. Animals were observed for 21 days with examination at 1, 24, 48, 72 h and 7, 14 and 21 days after test substance administration. Eye lesions were scored by the method of Draize.
Under the conditions of the present study, a single ocular application of the test item to rabbits produced adverse effects on cornea, iris and conjunctivae in all animals. The corneal injury persisted at termination of the study in two animals. The iridic irritation had resolved within 7 days after instillation in all three animals. The irritation of the conjunctivae had not resolved completely at termination of the study in all three animals. Neither mortalities nor clinical signs of toxicity were observed.
In this study, OO-tert-butyl monoperoxymaleate is corrosive to the eye and does warrant for classification as Eye Dam. Category 1 according to CLP criteria.
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.