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EC number: 403-610-9 | CAS number: 122795-41-9
- 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:
- Between 05 April 1988 and 13 April 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- -
- EC Number:
- 403-610-9
- EC Name:
- -
- Cas Number:
- 122795-41-9
- IUPAC Name:
- 1-ethyl-3-methoxytricyclo[2.2.1.0²,⁶]heptane; 2-ethyl-5-methoxybicyclo[2.2.1]heptane; 2-ethyl-6-methoxybicyclo[2.2.1]heptane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White strain rabbits in the weight range 2.0 to 3.0 kg, prior to treatment on Day 1 and approximately 9 to 13 weeks of age were obtained a reputable supplier. For full details please full study report. The rabbits selected for the study were all acclimated to the laboratory environment.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study.
The rabbits were individually housed in metal cages with perforated floors in Building R14 Room 5. They had free access to tap water and SDS Standard Rabbit Diet.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70%. Air exchange was maintained at approximately 19 air
changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
All animals were observed daily for signs of ill health or toxic signs.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 9 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square. A 0.5 ml aliquot of ethyl methoxy norbornane was applied under a 2.5 cm square gauze pad to one intact skin site on each animal.
- Type of wrap if used: Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period. The animals were not restrained during the exposure period and were returned to their cages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance.
EVALUATION OF SKIN REACTIONS
Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4. Additional observations were made on Days 5 to 9.
Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4. Additional observations were made on Days 5 to 9.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #27
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 9 d
- Irritation parameter:
- erythema score
- Basis:
- animal: #73
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 9 d
- Irritation parameter:
- erythema score
- Basis:
- animal: #74
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 9 d
- Irritation parameter:
- edema score
- Basis:
- animal: #27
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal: #73
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- edema score
- Basis:
- animal: #74
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- The numerical scores awarded to the dermal reactions elicited by ethyl methoxy norbornane are given in Table 1.
Well-defined erythema accompanied by very slight to slight oedema was observed in all three animals after removal of the dressings. The reactions resolved slowly and the skins were normal by Day 9 of the Study.
Any other information on results incl. tables
Dermal reactions elicited by ethyl methoxy norbornane
Rabbit Number and Sex |
E = Erythema O = Oedema |
Day |
||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
||
27♀ |
E |
2 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
0 |
O |
1 |
1 |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
|
73♀ |
E |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
O |
1 |
1 |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
|
74♀ |
E |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
O |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not skin irritant in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- Neoproxen is not considered to be a skin irritant.
- Executive summary:
The irritant effects of Neoproxen to rabbit skin was assessed in a GLP study according to OECD Guideline No. 404. Well-defined erythema accompanied by very slight to slight oedema was observed in all three animals after removal of the dressings. The reactions resolved slowly and the skins were normal by Day 9 of the Study.
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