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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-10-5 to 1996-01-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- The relative humidity (38-79%) exceeded the range specified in the protocol (40-70%). The p.m. mortality check was inadvertently not documented on study day 10 (10/29/95).
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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:
- other: paste
- Details on test material:
- - State of aggregation: paste
- Density: 1.03 g/mL
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Geneseo, NY
- Lot/batch No.of test material: 8968525407
- Expiration Date: March 10, 1996
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Below 100˚F
- Solubility of the test substance: Slight
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No prior treatment. The test article was administered as received from the Sponsor.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Sprague - Dawley Crl : CD BR VAF / Plus rats were used
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult
- Weight at study initiation: Males: 285-305 g, females: 240-257 g
- Housing: Animals were housed individually in suspended stainless steel cages. Housing and care was based on the standards recommended by the Guide for the Care and Use of Laboratory Animals.
- Diet (e.g. ad libitum): ad libitum, Purina Certified Rodent Chow #5002
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 61 - 73 ˚F
- Humidity (%): 38-79
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: 10
- Type of wrap if used: plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, residual test item was removed using gauze moistened with distilled water
- Time after start of exposure: 24 h
TEST MATERIAL
- Constant volume or concentration used: yes - Duration of exposure:
- approx. 24 h
- Doses:
- 2000 mg / kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations: Test animals were observed for clinical abnormalities two times on study day 0 (postdose) and daily thereafter (days 1-14). A mortality check was performed twice daily, in the morning and afternoon. Dermal observations were made following patch removal on study day 1 and daily thereafter days (2 - 14).
- Frequency of weighing: Individual body weights were obtained prior to dosing on day 0, on days 7 and 14 and at the time of death for any animal dying on study (except those that die on day 0)
- Necropsy of survivors performed: yes - Statistics:
- The LD50 value was estimated as follows:
< 50% mortality: LD50 was estimated as greater than the administered dose.
= 50% mortality: LD50 was estimated as equal to the administered dose.
> 50% mortality: L050 was estimated as less than the administered dose.
Body weight means and standard deviations were calculated separately for males and females for each limit level administered.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- One animal was found dead on Day 2.
- Clinical signs:
- other: Most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area, observed within the first three days of the study. For the animal that died, the clinical observations included decreased activity
- Gross pathology:
- For the animals that died, the most notable necropsy findings observed dark red mandibular lymph nodes, reddened mucosa in the stomach and congested meningeal vessels in the brain. No gross internal findings were observed at necropsy on day 14 for the surviving animals.
Any other information on results incl. tables
Table 1: Mortality during the limit test for the test item
Dose (mg/kg bw) |
No. Dead / No. Dosed |
||
|
Males |
Females |
Combined |
2000 |
0 / 5 |
1 / 5 |
1 / 10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the acute dermal LD50 of OO-tert-butyl monoperoxymaleate (25%) was estimated to be greater than 2000 mg/kg in the rat.
- Executive summary:
In an acute dermal toxicity study, similar to OECD 402, groups of young adult male and female Sprague – Dawley rats (5/sex) were dermally exposed to OO-tert-butyl monoperoxymaleate (25%) for 24 hours to 10% of body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 14 days. Under the conditions of this test, the acute dermal LD50 of OO-tert-butyl monoperoxymaleate (25%) was estimated to be greater than 2000 mg/kg in the rat.
Most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area, observed within the first three days of the study. For the animal that died, the clinical observations included decreased activity, wobbly gait, apparent hypothermia, urine stain, rough haircoat and dark material around the facial area. Dermal irritation was noted at the site of test article application for all animals.
Body weight loss was noted for three female rats during the study day 0-7 interval and one female rat during the study day 7-14 interval. Body weight gain was noted for all other surviving animals during the test period.
For the animals that died, the most notable necropsy findings observed dark red mandibular lymph nodes, reddened mucosa in the stomach and congested meningeal vessels in the brain. No gross internal findings were observed at necropsy on the last day.
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