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EC number: 279-967-8 | CAS number: 82461-14-1
- 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:
- June 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study may be used for classification purposes although there are deviations in its study protocol from the OECD TG 404. They do not include a 48-hour observation time and involve a 24-hour test material exposure followed by observations at 24 hour and 72 hours. Moreover, the test material is patched both on abraded and on intact skin of six rabbits per condition. The study is terminated after 72 hours.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Study may be used for classification purposes although there are deviations in its study protocol from the OECD TG 404. They do not include a 48-hour observation time and involve a 24-hour test material exposure followed by observations at 24 hour and 72 hours. Moreover, the test material is patched both on abraded and on intact skin of six rabbits per condition. The study is terminated after 72 hours.
- Principles of method if other than guideline:
- Study may be used for classification purposes although there are deviations in its study protocol from the OECD TG 404. They do not include a 48-hour observation time and involve a 24-hour test material exposure followed by observations at 24 hour and 72 hours. Moreover, the test material is patched both on abraded and on intact skin of six rabbits per condition. The study is terminated after 72 hours.
- GLP compliance:
- no
Test material
- Reference substance name:
- rel-(2R,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Cas Number:
- 99343-90-5
- Molecular formula:
- C12H16O
- IUPAC Name:
- rel-(2R,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Reference substance name:
- rel-(2S,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Cas Number:
- 99343-91-6
- Molecular formula:
- C12H16O
- IUPAC Name:
- rel-(2S,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Abraded or clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- Twelve animals (6 per condition)
- Details on study design:
- Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
Twelve healthy adult New Zealand White albino rabbits are used for 1-4 test substances. Twenty four hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An mount of 0.5 mL of the test substance is brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatiles substances.
Six rabbits are treated on the intact skin , the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours after application).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- Mean 24 and 72 hours
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Rhubafurane caused moderate skin irritation. The dermal effects observed after 24 hours generally consisted of slight or well-defined erythema and/or very slight edema. Very slight ischemia, focal haemorrhages and slight edema were noted at one intact and one abraded site.
After 72 hours slight to distinct scaliness was observed at five intact and three abraded sites while two abraded sites by then showed slight incrustation.
Any other information on results incl. tables
Table 1: Individual and Average Skin Irritation Scores of Pure and Undiluted Rhubafurane
Rabbit No. |
Intact skin |
Rabbit No. |
Abraded skin | ||||||
24 hours |
72 hours |
24 hours |
72 hours |
||||||
A |
B |
A |
B |
A |
B |
A |
B |
||
1 |
4 |
2 |
3 |
1 |
7 |
4 |
2 |
4 |
2 |
2 |
1 |
0 |
1 |
1 |
8 |
1 |
0 |
2 |
1 |
3 |
2 |
1 |
1 |
1 |
9 |
0 |
0 |
0 |
0 |
4 |
1 |
0 |
2 |
1 |
10 |
1 |
1 |
4 |
1 |
5 |
1 |
1 |
1 |
0 |
11 |
1 |
1 |
1 |
0 |
6 |
0 |
0 |
2 |
1 |
12 |
0 |
0 |
1 |
1 |
A = Erythema
B = Edema
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and the GHS.
- Executive summary:
In a dermal irritation study comparable to the OECD guideline 404, the primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
An amount of 0.5 mL of the test substance is brought on the intact or abraded skin of six healthy adult New Zealand White albino rabbits under a surgical patch fixed to the application site by means of adhesive tape.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours after application).Rhubafurane caused moderate skin irritation. The dermal effects observed after 24 hours generally consisted of slight or well-defined erythema and/or very slight edema. Very slight ischemia, focal haemorrhages and slight edema were noted at one intact and one abraded site. After 72 hours slight to distinct scaliness was observed at five intact and three abraded sites while two abraded sites by then showed slight incrustation.
However, to use this study for classification purposes although deviations in its study protocol from the OECDTG 404 were observed, it is feasible to use such data for classification by calculating the mean values for erythema and oedema on the basis of only the 24 and 72 hours time points. Calculation of mean scores are restricted to the results obtained from intact skin.
The mean scores calculated for each animal tested within 2 scoring times (24 and 72 h) were 3.5/1/1.5/1.5/1/1 for erythema and 1.5/0.5/1/0.5/0.5/0.5 for oedema.
Under the test conditions, the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and the GHS. This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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