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EC number: 231-185-8 | CAS number: 7443-25-6
- 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
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyl (p-methoxybenzylidene)malonate
- EC Number:
- 231-185-8
- EC Name:
- Dimethyl (p-methoxybenzylidene)malonate
- Cas Number:
- 7443-25-6
- Molecular formula:
- C13H14O5
- IUPAC Name:
- 1,3-dimethyl 2-[(4-methoxyphenyl)methylidene]propanedioate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF
- Details on test animals or test system and environmental conditions:
- Age at start of treatment: 14-15 weeks (male), 13-14 weeks (females)
Body weights at start of treatment: 2.3 - 2.9 kg
Identification: By unique cage number and corresponding ear number.
Acclimatization: Six days under laboratory conditions after health examination. Only animals without any visual signs of illness were used fior the study.
Allocation: Male No. 88, Female Nos. 89 and 90
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- The test item was administered at 0.5 g/animal, the dose specified in the test guidelines for a solid test item.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin irritation was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, after the removal of the dressing, gauze patch and test item.
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST ITEM PREPARATION:
0.5 g (per animal) of the test item was weighed as delivered by the sponsor and then moistened with bi-distilled water before application. According to Directive 92/69 EEC, B.4 and OECD Guidelines 404, a substance needs not to be tested if the pH-value is less than 2 or greater than 11.5, owing to its predictable corrosive properties. Prior to the application the pH of the test item was determined at a concentration of 1 % in water with pH-Test-Strip (E. Merck, D-64271 Darmstadt / Germany). The pH was found to be 6.
TREATMENT:
Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm² (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.5 g of test item was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to approximately 6 cm² of the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing [Isoelast Heftpflaster Acryl 8 x 75 cm]. The dressing was wrapped around the abdomen and anchored with tape. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
OBSERVATIONS:
Viability/Mortality: Daily from delivery of the animals to the termination of test.
Clinical signs: Daily from delivery of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cumulative (erythema and oedema score)
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- other: cumulative (erythema and oedema score)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- other: cumulative (erythema and oedema score)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- other: cumulative (erythema and oedema score)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable since no effect
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
VIABILITY/MORTALITY/CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
IRRITATION:
Application of the test item to healthy intact rabbit skin resulted in a primary irritation score of 0.22.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.22 erythema and grade 0.00 oedema.
A very slight erythema was observed in all animals at the 1 -hour observation before disappearing by 24 hours (one animal) or 48 hours (two animals). A very slight oedema was noted in one animal at the 1 -hour reading.
COLORATION:
No staining by the test item of the treated skin was observed.
CORROSION:
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
BODY WEIGHTS:
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993 and Regulation (EC) No. 1272/2008 (CLP)), the test item is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated by topical semi-occlusive application of 0.5 g to 6 cm² intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation score was 0.22 (max. 8.0).
Local signs (mean values from 24 to 72 hours) consisted of grade 0.22 erythema and grade 0.00 oedema.
A very slight erythema was observed in all animals at the 1 -hour observation before disappearing by 24 hours (one animal) or 48 hours (two animals). A very slight oedema was noted in one animal at the 1 -hour reading.
The test item caused no staining of the treated skin.
No corrosive effects were noted on the treated skin of any animal at any measuring interval.
Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993 and Regulation (EC) No. 1272/2008 (CLP)), the test item is considered to be "not irritating" to rabbit skin
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