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EC number: 219-868-9 | CAS number: 2556-10-7
- 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 corrosion: Substance is not skin and eye irritating and therefore also not corrosive.
Skin irritation (OECD TG 404): not irritating
Eye irritation (OECD TG 405): not irritating
Respiratory irritation: no adverse effects in absence of: human data indicating such. There is no concern because of absence of skin and eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure period was 24 h instead of 4 h, observation time points were 0 and 48 h after patch removal instead of 24, 48 and 72 h
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or test system and environmental conditions:
- No details provided
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- with electric clipper, avoiding abrasions
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml testing material
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 12 animals - 6 with intact skin and 6 with abraded skin (results for abraded skin are disregarded).
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 inch
- Type of wrap if used: surgical patch, fixed to application site with adhesive tape and entire trunk of rabbits is wrapped with impervious material.
OBSERVATION TIME POINTS
After 24 hours from the start of exposure (so directly after exposure, at time point 0 h after patch removal) and after 72 hours (so at time point 48 h after patch removal)
SCORING SYSTEM:
- Method of calculation: Draize (J. Pharmacol. 82 (1944) 377-390) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 0 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 0 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 0 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritant / corrosive response data:
- The test substance caused moderate skin irritation. Its dermal effects observed after 24 hours of exposure (so at time point 0 h after patch removal) generally consisted of very slight to moderate erythema and very slight edema. Dermal effects observed after 72 hours after exposure (so at time point 48 h after patch removal) consisted of very slight or well-defined erythema, slight scaliness and very slight edema.
- Interpretation of results:
- other: Not a skin irritant
- Remarks:
- Based on EU CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Hyacinth body was tested in a study similar to OECD TG 404 and based on the results it was concluded not to be a skin irritant.
- Executive summary:
The skin irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD TG 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. In this study, 12 New Zealand white rabbits were used, 6 with intact skin and 6 with abraded skin. 24 hours prior to dosing the hair was removed from the back with a clipper. 0.5 mL testing material was applied on the skin under a surgical patch 1x1 inch. After the exposure period of 24 hours patches were removed. Only testing results of animals with intact skin were considered for evaluation of skin irritation. Observations made directly upon patch removal are treated as time point 0 h and the observations made at 48 hours after patch removal are treated as time point 48 h. The 24 h and 72 h time points were not scored, therefore the only 48 h results could be taken into consideration. Effects observed upon patch removal (so at time point 0 h) were limited. Slight to moderate erythema was observed (1 animal with score 3, 2 animals with score 2, 2 animals with score 1 and 1 animal with score 0) and none to slight edema (3 animals with score 1 and 3 animals with score 0). This was not sufficient to consider the substance a skin irritant. The decreased presence of dermal effects observed 48 hours after patch removal supports this finding. A slight to moderate erythema was then observed (1 animal scored 2 and 2 animals scored 1), none to slight edema (1 animal scored 1 and 5 animals scored 0) and a slight scaliness. Under the conditions of this test, some erythema and edema effects were observed directly after patch removal but only an erythema score for one animal was above the classification threshold. When taking the results from 48 h, though, none of the animals exceeded the score 2.3 for erythema or oedema (which is a criterion for EU CLP classification). Given the longer exposure period of 24 instead of 4 hours and the test results obtained, it can be concluded that Hyacinth body is not an irritant to skin.
- 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
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
To be able to derive a CLP classification from skin irritation test results, normally the 24, 48 and 72 hours timepoints (after patch removal) for erythema and edema are used. In this study only the 48 hours timepoint is available for evaluation. As supporting evidence the reading directly after removal of the patch is available (0 hours timepoint), which can be considered the worst-case effect. Based on the available eythema and edema scores and given the longer exposure period (24 instead of 4 hours), it is concluded that classification for CLP purposes can be assessed with the current test as it can be seen as a worst-case.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No examination was done 1 hour after instillation, observation for 7 days.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: caged individually
- Other: the animals receive no hay or other extraneous material that might enter the eyes - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL testing material
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize and Kelley (1952)
The eyes of the animals were examined before testing and only those animals without observable eye defects were used.
The test material is allowed to fall on the everted lower lid of one eye of each rabbit and 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 eyes were not washed following the installation and the animals were released immediately. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1, 2 and 4
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 5 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight redness of the conjunctivae in four out of six rabbits and slight swelling of the conjunctivae in one out of six rabbits were noted. After seven days all lesions cleared up.
- Interpretation of results:
- other: Not an eye irritant
- Remarks:
- Based on EU CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this test (simialr to OECD TG 405), Hyacinth body is not considered to be an eye irritant.
- Executive summary:
The eye irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD 405 but with (acceptable) deviations on the observation period and therefore a Klimisch 2 rating was assigned. In this study, 6 New Zealand white rabbits were used. Prior to instillation, eyes of the animals were examined for visible eye defects. 0.1 mL of testing material per animal was instilled in one eye and the other eye served as control. Eyes were not washed after instillation. Animals were observed at 24, 48, 72 and 7 days after instillation. No cornea and iris effects were noted. Slight redness of the conjunctivae in four out of six rabbits was seen (score 1 in 1 animal and score 0.66 in 3 animals; out of max. score 3), as well as a slight swelling of the conjunctivae in one out of six rabbits was noted (score 0.33 out of max. score 4). After seven days all lesions had cleared up. Under the conditions of this test, Hyacinth body is not considered to be an eye irritant.
- 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
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The skin irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD TG 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. In this study, 12 New Zealand white rabbits were used, 6 with intact skin and 6 with abraded skin. 24 hours prior to dosing the hair was removed from the back with a clipper. 0.5 mL testing material was applied on the skin under a surgical patch 1x1 inch. After the exposure period of 24 hours patches were removed. Only testing results of animals with intact skin were considered for evaluation of skin irritation. Observations made directly upon patch removal are treated as time point 0 h and the observations made at 48 hours after patch removal are treated as time point 48 h. The 24 h and 72 h time points were not scored, therefore the only 48 h results could be taken into consideration. Effects observed upon patch removal (so at time point 0 h) were limited. Slight to moderate erythema was observed (1 animal with score 3, 2 animals with score 2, 2 animals with score 1 and 1 animal with score 0) and none to slight edema (3 animals with score 1 and 3 animals with score 0). This was not sufficient to consider the substance a skin irritant. The decreased presence of dermal effects observed 48 hours after patch removal supports this finding. A slight to moderate erythema was then observed (1 animal scored 2 and 2 animals scored 1), none to slight edema (1 animal scored 1 and 5 animals scored 0) and a slight scaliness. Under the conditions of this test, some erythema and edema effects were observed directly after patch removal but only an erythema score for one animal was above the classification threshold. When taking the results from 48 h, though, none of the animals exceeded the score 2.3 for erythema or oedema (which is a criterion for EU CLP classification). Given the longer exposure period of 24 instead of 4 hours and the test results obtained, it can be concluded that Hyacinth body is not an irritant to skin.
Eye irritation
The eye irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD 405 but with (acceptable) deviations on the observation period and therefore a Klimisch 2 rating was assigned. In this study, 6 New Zealand white rabbits were used. Prior to instillation, eyes of the animals were examined for visible eye defects. 0.1 mL of testing material per animal was instilled in one eye and the other eye served as control. Eyes were not washed after instillation. Animals were observed at 24, 48, 72 and 7 days after instillation. No cornea and iris effects were noted. Slight redness of the conjunctivae in four out of six rabbits was seen (score 1 in 1 animal and score 0.66 in 3 animals; out of max. score 3), as well as a slight swelling of the conjunctivae in one out of six rabbits was noted (score 0.33 out of max. score 4). After seven days all lesions had cleared up. Under the conditions of this test, Hyacinth body is not considered to be an eye irritant.
Respiratory irritation
Respiratory irritation is not anticipated because there are no human data indicating such effects. In addition, the substance is not a skin or eye irritant under in vivo conditions, which further supports the absence of concern for respiratory irritation.
Justification for classification or non-classification
Based on the results of the skin and eye irritation tests it can be concluded that Hyacinth Body does not need to be classified as a skin, eye or respiratory irritant according to EU CLP (EC No. 1272/2008 and its amendments).
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