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EC number: 220-599-4 | CAS number: 2832-30-6
- 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
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- Nanomaterial crystallite and grain size
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- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- 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; according to 16 CFR 1500.41; RL2; pre-GLP; 24h/72h average edema score: 0.5 in four animals and 0 in the other two animals
-eye irritation: not irritating; according to 16 CFR 1500.41; RL2; pre-GLP; small opacity spots (score 0.33) in two animals after 24 hours of application and discharge of conjunctivae (score 0.67) in one animal after 24 hours of application; all fully reversible after 48 hours of application.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- GLP compliance:
- no
- Remarks:
- Study conducted prior to implementation of GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht / Extertal 1
- Weight at study initiation: 2.1 kg (average)
- Housing:individual cages
- Diet (e.g. ad libitum): "mümmel z" (ssniff / Soest)
- Water (e.g. ad libitum): yes
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40 r.h.
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: both sides of trunk clipped, one side with additional scarification
- Vehicle:
- other: oil
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg/ gauze
VEHICLE
- oil - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 30 minutes after end of application followed by 48 and 72 hrs after start of application, observation control after 8 d
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm on both sides of the trunk (one side intact, the other side scarified)
- Type of wrap if used: double layer of surgical gauze, covered with impermeable PVC foil, fixed with Leukoflex on both sides of the trunk, elastic bandage, animals were immobilized during exposure.
OBSERVATION TIME POINTS
30 minutes after end of application followed by 48 and 72 hours after start of application (observation results after 48 hours not stated in report), observation control after 8 days - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Remarks:
- h
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Remarks:
- h
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Remarks:
- h
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Remarks:
- h
- Remarks on result:
- other:
- Remarks:
- scarificed skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Remarks:
- h
- Remarks on result:
- other:
- Remarks:
- scarificed skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarificed skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Remarks:
- h
- Remarks on result:
- other:
- Remarks:
- scarificed skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarificed skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarificed skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- not determined
- Remarks on result:
- other:
- Remarks:
- not determined
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarified skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarified skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarified skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarified skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarified skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0
- Remarks on result:
- other:
- Remarks:
- scarified skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring of skin by testing material.
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring of skin by testing material.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- not determined
- Remarks on result:
- other:
- Remarks:
- not determined
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- scoring not possible due to colouring
- Remarks on result:
- other:
- Remarks:
- scoring not possible due to colouring
- Irritant / corrosive response data:
- Erythema: due to colouring of the skin by testing material no scoring could be conducted.
Edema: four animals (#1 to #4) showed very slight edemae on intact skin within 24 hours after application start, which were fully reversible within 48 hours. Slight and very slight edemae were observed within 24 hours after application start on scarified skin in animals #2 and #4, respectively, which were fully reversible within 48 hours. No effects were observed in any other animal during the observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- 5,8-Dichlorchinizarin was not irritating in the in vivo skin irritation test under the experimental conditions described in this report.
- Executive summary:
In a primary dermal irritation study performed in accordance with the Code of Federal Regulations, Title 16, Section 1500.41, adult albino rabbits (strain New Zealand White) were dermally exposed to 500 mg of 5,8-Dichlorchinizarin (vehicle: oil) under occlusive conditions for 24 hours to 2 x 6.25 cm² body surface area. Animals were then observed for 8 days.
Erythema was not scored due to colouring of skin by testing material. Edema scores of 1 were observed in 4 out of 6 animals (#1-#4) within 24 hours after application start in which animal #2 and #4 also showed effects on scarified skin with a score of 2 and 1, respectively. The 24h/72h average edema score was 0.5 in four animals and 0 in the other two animals. However, both irritation scores lead to classification as non-irritating.
In this study, 5,8-Dichlorchinizarin is not a dermal irritant.
Reference
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (results from intact skin, only)
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
** |
1/1/1/1/0/0 |
48 h (not measured) |
** |
-- |
72 h |
** |
0/0/0/0/0/0 |
Average 24h/72h |
** |
0.5/0.5/0.5/0.5/0/0 |
Reversibility*) |
** |
c/c/c/c/--/-- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**) scoring not possible due to colouring of skin by testing material
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- GLP compliance:
- no
- Remarks:
- Study conducted prior to implementation of GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht / Extertal 1
- Weight at study initiation: 2.1 kg (average)
- Housing: individual cages
- Diet (e.g. ad libitum): "mümmel z" (ssniff / Soest)
- Water (e.g. ad libitum): yes
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40 r.h.
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 µL bulk volume/animal - Duration of treatment / exposure:
- >1 sec (application in conjunctival sac of right eyelids, manually closed for 1 sec, eyes not rinsed after treatment)
- Observation period (in vivo):
- 24, 48 and 72 h after start of application, observation control after 8 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, 1959, p.51
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- score = 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- score = 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- score = 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- score = 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other:
- Remarks:
- score = 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other:
- Remarks:
- score = 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- cornea opacity: <=25% of cornea size with opacity spots, iris clearly visible in animals #1 and #2 within 24 hours of application (fully reversible within 24 hours); all other animals showed cornea and iris score 0.
conjunctivae: discharge with wetted eyelids and hairs directly at eyelids in one animal (#6) within 24 hours of application (fully reversible within 24 hours); all other animals showed score 0 on conjunctivae - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, 5,8-Dichlorchinizarin was not irritating to the eyes.
- Executive summary:
In a primary eye irritation study performed in accordance with the Code of Federal Regulations, Title 16, Section 1500.41, 5,8-Dichlorchinizarin was instilled into the conjunctival sac of 6 albino rabbits (strain New Zealand White). Animals then were observed for 7 days. Irritation was scored by "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, 1959, p.51.
Animals #1 and #2 showed opacity spots on cornea and clear iris within 48 hours of application (score 1). Animal #6 showed discharge at conjunctiva within 24 hours of application. All observed effects were fully reversible within 48 hours). No irritation occurred in any other animal during the entire observation period.
In this study, 5,8-Dichlorchinizarin is not an eye irritant.
Reference
Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test | ||||
Score at time point / Reversibility | Cornea | Iris | Conjunctivae | Chemosis |
Max. score: 4 | Max. score: 2 | Max. score: 3 | Max. score: 4 | |
24 h | 1/1/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/2 | 0/0/0/0/0/0 |
48 h | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
72 h | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
Average 24h, 48h, 72h | 0.33/0.33/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0.67 | 0/0/0/0/0/0 |
Area effected | <=25%/<=25%/0/0/0/0 | -- | -- | -- |
Maximum average score (including area affected, max 110) | ||||
Reversibility*) | c/c/--/--/--/-- | --/--/--/--/--/-- | --/--/--/--/--/c | --/--/--/--/--/-- |
Average time (unit) for reversion | 48 hrs | -- | 48 hrs | -- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation
Based on reliable, adequate and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.
Eye irritation
Based on reliable, adequate and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.
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