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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
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating (no guideline followed, K, Rel.2)
Eye irritation: not irritating (equivalent to OECD 405, K, Rel.2)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Justification for type of information:
- In accordance with section 1.1 (Use of existing data) of Annex XI to the REACH Regulation, the in-vitro skin irritation study (required in section 8.1) does not need to be conducted as a reliable in-vivo study is available and provides sound conclusive evidence that the substance is non-irritating.
- 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.
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not reported
- 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). - 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. - 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.
Referenceopen allclose all
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- In accordance with section 1.1 (Use of existing data) of Annex XI to the REACH Regulation, the in-vitro eye irritation study (required in section 8.2) does not need to be conducted as a reliable in-vivo study is available and provides sound conclusive evidence that the substance is non-irritating.
- Endpoint:
- eye 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:
- Techniques published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug. Cosmet. Industr. 71 (1952) 36) are followed.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Deviations to the OECD guideline 405: No 1 hour and 14-day observation period and 6 animals used instead of 3
- Principles of method if other than guideline:
- Techniques published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug. Cosmet. Industr. 71 (1952) 36) are followed.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Not reported
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.
- Observation period (in vivo):
- 24, 48, 72 hours and 7 days after the instillation.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six New Zealand White albino rabbits are used for each test substance. The animals are caged individually and receive no hay or other extraneous material that might enter the eyes.
The eyes of the animals are examined before testing and only those animals without observable eye defects are used. One tenth of a milliliter of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, serves as a control.
The eyes are not washed following instillation and the animals are released immediately.
The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
An animal is considered as giving a positive reaction if there is, at any of the readings, discernible opacity of the cornea (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection), or if such substance produces in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA-scoring is used.
The test is considered positive if four or more of the animals in the test group of six rabbits exhibit a positive reaction. If one animal exhibits a positive reaction, the test is regarded as negative.
If two or three animals exhibit a positive reaction, the test is repeated, using a different group of six animals. The second test is considered as positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test exhibit a positive reaction, the test is again repeated with a different group of six animals. Should a third test be needed, the substance will be regarded as an irritant if two or more animals exhibit a positive response. - Irritation parameter:
- chemosis score
- Basis:
- animal: #11 and #12
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #10
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #9
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #7 and #8
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #12
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #11
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #10
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #9
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #7 and #8
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #11 and #12
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #9 and #10
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #7 and #8
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #9, #10 and #11
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #12
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The test product caused slight corneal opacity in three rabbits (No.7, 8 and 12), slight iritis in four rabbits (No.7, 8, 11 and 12) and slight or moderate redness and swelling of the conjunctivae in all animals. In the course of the seven-day observation period these lesions cleared up, except for slight redness of the conjucntivae, noted in two animals (No.7 and 8) at the seventh day.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item is not classified as irritant to the eyes according to the Regulation (EC) No. 1272/2008 (CLP) and to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
In an eye irritation study performed according to an equivalent study following the OECD Guideline No. 405 protocol, New Zealand White albino rabbits are used for assess the eye irritant potential of the test material.
0.1 mL of undiluted test item was instilled into the right eye of 6 rabbits. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test item, and then released. The left eye remained untreated and served as control. The eyes were examined and the changes were observed at 24, 48, 72 h and 7 days after instillation of test item and graded according to the Draize method.
The eyes are not washed following instillation and the animals are released immediatelyThe test product caused slight corneal opacity in three rabbits (No.7, 8 and 12), slight iritis in four rabbits (No.7, 8, 11 and 12) and slight or moderate redness and swelling of the conjunctivae in all animals. In the course of the seven-day observation period these lesions cleared up, except for slight redness of the conjucntivae, noted in two animals (No.7 and 8) at the seventh day.
Mean individual scores at 24, 48 and 72 h after exposure for the 6 animals were 1 / 1 / 0 / 0 / 0 / 0.6 for cornea score; 0.3/ 0.6 / 0 / 0 / 0.3 / 0.3 for iris score; 1.6 / 1.6 / 1 / 0.6 / 1.3 / 1.3 for conjunctivae score and 2 / 2 / 0.6 / 0.6 / 1 / 1 for chemosis score.
Under the test conditions, the test item is not classified as irritant to the eyes according to the Regulation (EC) No. 1272/2008 (CLP) and to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Referenceopen allclose all
Table 1: Individual Scores Awarded to the Occular Lesions Elicted by the Rhubafurane
Time point |
Rabbit Number |
Cornea |
Iris |
Conjunctivae |
|
Redness |
swelling |
||||
After 24 hours |
7 |
1 |
0 |
2 |
2 |
8 |
1 |
1 |
2 |
2 |
|
9 |
0 |
0 |
1 |
1 |
|
10 |
0 |
0 |
1 |
1 |
|
11 |
0 |
1 |
2 |
2 |
|
12 |
1 |
1 |
2 |
2 |
|
After 48 hours |
7 |
1 |
1 |
2 |
2 |
8 |
1 |
1 |
2 |
2 |
|
9 |
0 |
0 |
1 |
0 |
|
10 |
0 |
0 |
1 |
1 |
|
11 |
0 |
0 |
2 |
1 |
|
12 |
1 |
0 |
1 |
1 |
|
After 72 hours | 7 |
1 |
0 |
1 |
2 |
8 |
1 |
0 |
1 |
2 |
|
9 |
0 |
0 |
1 |
1 |
|
10 |
0 |
0 |
0 |
0 |
|
11 |
0 |
0 |
0 |
0 |
|
12 |
0 |
0 |
1 |
0 |
|
After 7 days |
7 |
0 |
0 |
1 |
0 |
8 |
0 |
0 |
1 |
0 |
|
9 |
0 |
0 |
0 |
0 |
|
10 |
0 |
0 |
0 |
0 |
|
11 |
0 |
0 |
0 |
0 |
|
12 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A key study was identified (TNO, 1981).
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.
Although deviations from the OECDTG 404 were observed in the study protocol, it is however 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.
Eye irritation:
A key study was identified (TNO, 1981).
In an eye irritation study performed according to an equivalent study following the OECD Guideline No. 405 protocol, New Zealand White albino rabbits are used for assess the eye irritant potential of the test material.
0.1 mL of undiluted test item was instilled into the right eye of 6
rabbits. The upper and lower eyelids were held together for about one
second immediately after application, to prevent loss of the test item,
and then released. The left eye remained untreated and served as
control. The eyes were examined and the changes were observed at 24, 48,
72 h and 7 days after instillation of test item and graded according to
the Draize method.
The eyes are not washed following instillation and the animals are
released immediately
The test product caused slight corneal opacity in three rabbits (No.7, 8 and 12), slight iritis in four rabbits (No.7, 8, 11 and 12) and slight or moderate redness and swelling of the conjunctivae in all animals. In the course of the seven-day observation period these lesions cleared up, except for slight redness of the conjucntivae, noted in two animals (No.7 and 8) at the seventh day.
Mean individual scores at 24, 48 and 72 h after exposure for the 6 animals were 1 / 1 / 0 / 0 / 0 / 0.6 for cornea score; 0.3/ 0.6 / 0 / 0 / 0.3 / 0.3 for iris score; 1.6 / 1.6 / 1 / 0.6 / 1.3 / 1.3 for conjunctivae score and 2 / 2 / 0.6 / 0.6 / 1 / 1 for chemosis score.
Under the test conditions, the test item is not classified as irritant to the eyes according to the Regulation (EC) No. 1272/2008 (CLP) and to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Based on the available data:
No additional self-classification is proposed regarding skin and eye irritation and the test substance is not classified according to the criteria of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- No data was available regarding respiratory irritation.
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