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EC number: 231-403-1 | CAS number: 7534-94-3
- 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:
- 7 to 14 Oct 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate
- EC Number:
- 231-403-1
- EC Name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate
- Cas Number:
- 7534-94-3
- Molecular formula:
- C14H22O2
- IUPAC Name:
- 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): IBOMA Isobornyl methacrylate
- Physical state: Clear colourless liquid
- Storage condition of test material: Ambient temperature (10 °C to 30°C), protected from light
- Expiry date: November 04, 2017
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.49 - 2.70 kg
- Housing: in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 49 - 56 %
- Air changes (per hr): 15 changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted test substance - Duration of treatment / exposure:
- 3 min, 1 hour and 4 hour(s)
- Observation period:
- 24, 48, 72 hours and 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: no data availible
- Type of wrap if used: gauze patches, placed in position on the shorn skin, secured in position with strips of surgical adhesive tape, the trunk of each rabbit was wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage. Residual test material was removed by gentle swabbing with cotton wool soaked with diethyl ether.
- Time after start of exposure: 24, 48 and 72 hours
SCORING SYSTEM: Draize JH (1959) scale
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- intact skin; evaluation of erythema and oedema
- Basis:
- mean
- Remarks:
- Classification according to Draize score (Draize JH, 1959)
- Time point:
- other: 24 and 72 hours
- Score:
- 4
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Original data, evaluation according to Draize JH, 1959, moderate irritant No corrosive effects were noted. Crust formation was noted at all treated skin sites seven days after treatment.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 7 days
- Remarks on result:
- other: Evaluation according to Draize JH, 1959. No corrosive effects were noted. Crust formation was noted at all treated skin sites seven days after treatment.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluation according to Draize JH, 1959. No corrosive effects were noted. Crust formation was noted at all treated skin sites seven days after treatment.
Any other information on results incl. tables
Classification of skin irritation studies according to OECD 404 / EU-GHS / UN-GHS criteria
Substance: Isobornyl methacylate IBOMA CAS: 7534 -94 -3
Internal No.: LITSU 11 -0007
Date/Expert: 09 June 2011/RG
Overall primary irritation score (PDII): 4 of 8 scores FDA (Draize), 1959,
re-evaluated according to OECD 404
|
Animal No. |
Erythema/Eschar formation [Scores] |
Mean Draize score (24 , 48, 72 h) |
Oedema formation [Scores] |
Mean Draize score |
Hazard category EU-GHS |
Hazard category UN-GHS |
||||||
24 h |
48 h |
72 h |
7 days |
24 h |
48 h |
72 h |
7 days |
|||||
1 |
2 |
2 |
2 |
0crust formation |
2 |
2 |
2 |
2 |
0 |
2 |
|
|
2 |
2 |
2 |
2 |
0crust formation |
2 |
2 |
2 |
2 |
0 |
2 |
|
|
3 |
2 |
2 |
2 |
0crust formation |
2 |
2 |
2 |
2 |
0 |
2 |
|
|
|
|
|
|
|
2 |
|
|
|
|
2 |
None |
Cat. 3 |
Classification criteria according to the different classification systems:
EU-GHS: Category 1: Corrosive subcategories
Corrosive in >= 1 of 3 animals (applies to authorities not using subcategories): Corrosive (only applies to some authorities) Subcat. Exposure Observation 1A <= 3 minutes <= 1 hour 1B > 3 minutes -- <= 1 hour <= 14 days 1C > 1 hour -- <= 4 hours <= 14 days A single harmonized corrosion category is provided in Table 3.2.1, using the results of animal testing. A corrosive is a test material that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 of 3 tested animals after exposure up to a 4 hour duration. Corrosive reactions are typified by ulcers, bleeding, bloody scabs and, by the end of observation at 14 days, by discoloration due to blanching of the skin, complete areas of alopecia and scars. Histopathology should be considered to discern questionable lesions.
A mixture is considered corrosive (Skin Category 1) if it has a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/acid reserve suggests the substance or preparation may not be corrosive despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.
Category 2 (1) Mean value of >= 2.3 - < 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or (2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or (3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well defined erythema and slight to
moderate oedema. Crust formation was noted at all treated skin sites seven days after treatment. The test material produced a primary irritation
index of 4.0 out of 8 and was classified as a moderate irritant to rabbit skin according to the Draize classificatiobn scheme. No corrosive effects were
noted.
According to EU Classification: not classified, no classification and labelling
According to GHS criteria UN category: 3 - Executive summary:
In a primary dermal irritation study New Zealand White rabbits were dermally exposed (intact shaved skin, semi-occlusive) to 0.5 mL Isobornylmethacrylate for 4 hours. Animals then were observed for 7 days. Irritation was scored by the method of Draize et al, 1959. The mean erythema score (average value of the single scores (animals 1 -3; erythema; intact skin, 24h and 72h) was determined to be 2 out of 4 and, accordingly, the mean edema score 2 out of 4.
The results demonstrate that Isobornylmethacrylate is not a dermal irritant according to EU-GHS criteria (EU-GHS-hazard category: none).
Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed according to OECD 404. The results of the study were evaluated according to different evaluation-criteria (please see any other information on results inclusive tables).
EU-GHS Classification: not classified, no classification and labelling, According to GHS criteria UN category: 3 (mild irritant)
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