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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-502-5 | CAS number: 141-79-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylpent-3-en-2-one
- EC Number:
- 205-502-5
- EC Name:
- 4-methylpent-3-en-2-one
- Cas Number:
- 141-79-7
- Molecular formula:
- C6H10O
- IUPAC Name:
- 4-methylpent-3-en-2-one
- Details on test material:
- - Name of test material (as cited in study report): Mesityl Oxide
- Physical state: liquid
- Analytical purity: 99.87%
- Purity test date: 16 April 2010
- Lot/batch No.: A1YB3N010101
- Expiration date of the lot/batch: 16 April 2012
- Storage condition of test material: Ambient condition
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan England, Hillcrest, Dodgeford Lane, Belton, Loughborough, Leicestershire, LE12 9TE, England.
- Age at study initiation: approximately 15 to 17 weeks
- Weight at study initiation: 3.06 to 3.33 kg
- Housing: 1/cage; grid-bottomed metal cages suspended over trays measuring 48x41x63 cm
- Diet (e.g. ad libitum): ad libitum - STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK
- Water (e.g. ad libitum): ad libitum - Tap water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): aproximately 15 to 25
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 6 to 22 June 2010
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site; 1 site/animal
- Concentration (if solution): as supplied - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: the test item was spread evenly over a square gauze measuring 2.5x2.5 cm.
The square gauze was then placed onto the animal’s skin with the test item in direct contact with the skin.
A strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale
Erythema and eschar formation
0 - No erythema
1 -Slight erythema
2 - Well defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beef redness) to eschar formation preventing grading of erythema
Oedema formation
0 -No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well defined by definite raising)
3 - Moderate oedema (raised approximately 1mm)
4 - Severe oedema (raised more than 1 mm and extending beyond the area of exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 to 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Score of 1 recorded also 7 days after treatment; see histopathology
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Presence of desquamation 7 and 14 days after treatment; see histopathology
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 to 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Score of 1 or 3 recorded respectively 7or 14 days after treatment; see histopathology
- Irritation parameter:
- edema score
- Basis:
- animal: # 1, 2 and 3
- Time point:
- other: 24 h to 14 days
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Reaction at the treatment site was recorded in the following three animals:
Rabbit no. 80720001: slight erythema (score of 1) was recorded from 24 hours to 7 days after dosing. No reaction was observed on Day 15. No oedema was observed.
The calculated mean erythema and oedema scores over 24, 48 and 72 hours were 1.0 and 0.0, respectively.
Rabbit no. 80720003: No erythema or oedema (score 0) occurred at the treatment site up to 72 hours after dosing. Desquamation of the treatment site was recorded on Days 8 and 15. No oedema was observed.
The calculated mean erythema and oedema scores over 24, 48 and 72 hours were 0.0.
Rabbit no. 80720005: Well defined erythema (score of 2) was recorded 1 and 24 hours after dosing. Slight erythema (score of 1) at 48 hours, 72 hours and 7 days. Moderate to severe erythema (score of 3) was finally recorded on Day 15. No oedema was observed.
The calculated mean erythema and oedema scores over 24, 48 and 72 hours were 1.3 and 0.0, respectively. - Other effects:
- Macroscopic observations
The treatment site showed multiple scabs (up to 1x1 mm) in the female no. 3 and multiple red areas in the cutis (up to 25x8 mm) were noted in the female no. 5, while no macroscopic change at the treatment site was noted in female no. 1.
Microscopic observations
The histopathological evaluation of the above-mentioned treatment sites revealed in female no. 1 focal slight acute inflammation in the dermis and in the female no. 80720003 focal scabs and chronic inflammatory reaction in the dermis.
Female no. 80720005 showed a most relevant pathological change in the treatment site such as multifocal mild haemorrhage associated to hyperplasia of follicular basal cell (hair follicles) and squamous cell layer with acanthosis of the epidermis.
As reported in the literature, the follicular basal cell hyperplasia may be considered to contribute to repair the epidermal wounding.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information based on the histopathological examinations Criteria used for interpretation of results: expert judgment
- Conclusions:
- These results indicate that the test item, Mesityl oxide, has an irritant effect on the skin of the rabbit following a 4 hour dermal exposure period, even though with a high individual variability. Reaction was moderately stronger in one animal and recovery was not completed in two animals at the end of the 14-day observation period.
- Executive summary:
The acute dermal irritation of Mesityl oxide (purity 99.87%) was investigated in the rabbit in an OECD 404 study. A 0.5 mlaliquot of the substance was applied to the clipped dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed approximately 1, 24, 48, 72 hours, 7 and 14 days after the end of the exposure period. In the first rabbit slight erythema (score of 1) was recorded from 24 hours to 7 days after dosing. No reaction was observed on Day 15 (calculated mean erythema score over 24, 48 and 72 hours equal to 1.0). No oedema was observed. In the second rabbit, no erythema or oedema (scores of 0) occurred at the treatment site up to 14 days after dosing. Desquamation of the treatment site was recorded on Days 8 and 15. In the third rabbit, well defined erythema (score of 2) was recorded 1 and 24 hours after dosing, slight erythema (score of 1) at 48 hours, 72 hours and 7 days. Moderate to severe erythema (score of 3) was finally recorded on Day 15 (calculated mean erythema score over 24, 48 and 72 hours equal to 1.3). No oedema was observed. There was no indication of a systemic effect of treatment. Body weight changes were not remarkable. The histopathological evaluation of the treatment sites revealed, a focal and slight acute inflammation in the dermis in the 1stfemale, focal scabs and chronic inflammatory reaction in the dermis in the 2ndfemale and a multifocal and mild haemorrhage associated to hyperplasia of follicular basal cell (hair follicles) and squamous cell layer with acanthosis of the epidermis in the 3rdfemale. As reported in the literature, the follicular basal cell hyperplasia may be considered to contribute to repair the epidermal wounding. These results indicate that the test item, Mesityl oxide, has an irritant effect on the skin of the rabbit following a 4-hour dermal exposure period, even though with a high individual variability. Reaction was moderately stronger in one animal and recovery was not completed in two animals at the end of the 14-day observation period.
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.