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EC number: 943-434-4 | CAS number: -
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed similar to OECD 405 guideline but without GLP. Limited information on test material and environmental conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- The extent of DHT-4A ocular mucous membrane-stimulating effects were investigated in rabbits using the Draize's rating scale.
- GLP compliance:
- no
Test material
- Reference substance name:
- Aluminium magnesium carbonate hydroxide
- EC Number:
- 943-434-4
- Cas Number:
- 11097-59-9
- Molecular formula:
- [Al2Mg4(OH)12] CO3
- IUPAC Name:
- Aluminium magnesium carbonate hydroxide
- Details on test material:
- Chemical Formula: Mg4.5AL2(OH)13CO3 3.5H2O
Chemical nomenclature: Hydrotalcite DHT-4A
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: male Japanese rabbits (Yugengaisha Ichikaway)
- Details on test animals or tissues and environmental conditions:
- Healthy white Japanese rabbits weighing approximately 3kg (Yugengaisha I chikawaya ) were used for this study .
All were male, totaling 9. Solid food manufactured by Clea Japan Inc. (CR-l) and normal drinking water in a bottle were taken ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg of undiluted test drug was dropped into the everted lower lid;
upper and lower lids were separated after light contact. - Duration of treatment / exposure:
- The rabbits were divided into the 3 whose eyes were not washed after treatment, the 3 those whose eyes were washed with 20ml of mild warm water 2 seconds after treatment, and the 3 those whose eyes were washed with 20 ml of tepid water 4 seconds after treatment.
- Observation period (in vivo):
- All rabbits were observed 1, 2, 3, 4 and 7 days later and evaluated according to rating criteria.
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- The experiment was carried out according to the following procedure .
(a ) Nine white male Japanese rabbits (weighing approximately 3kg ) , adjudged normal following a cornea test with fluorescein paper (Haag-streit ag
liebefed-dern Switzerland) were used .
(b) The test drug was dropped into the right eye, the left eye being left untreated for comparison. 100 mg of undiluted test drug was dropped into the everted lower lid; upper and lower lids were separated after light contact.
(c) The rabbits were divided into the 3 whose eyes were not washed after treatment, the 3 those whose eyes were washed with 20ml of mild warm
water 2 seconds after treatment,and the 3 those whose eyes were washed with 20 mL of tepid water 4 seconds after treatment.
(d) all the rabbits were observed 1,2,,3,4, and 7 days later and evaluated according to rating criteria.
(e) after 7- days of observation the animals were killed for autopsy; the upper and lower eyelids, nicititating membranes eyeballs and optic nerves were removed and preserved in formalin fixative.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1, #2 and #3
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1, #2 and #3
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal #1 and #3
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1 and #2
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: eyes not washed
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: eyes not washed
- Irritant / corrosive response data:
- In ocular response to DHT-4A undiluted, chief symptoms were conjunctival changes , whereas there were no changes in the cornea or iris.
1. Rabbits whose eyes were not washed
On the first day of eye - dropping, accelerated congestion of the conjunctiva was noted in two of the three rabbits,
while exaggerated conjunctival edema and excess discharge were observed in the other .
However, on the second day of eye-dropping , conjunctival congestion , edema and discharge began to disappear .
2. Rabbits whose eyes were washed 2 seconds after treatment.
On the first day of eye-dropping, excessive discharge was observed in two out of the three.
On the second day of eye-dropping , such disc harge began to cease.
3 . Rabbits whose eyes were washed 4 seconds after treatment .
On the first day of eye-dropping, accelerated conjunctival congestion was noticed in two of the three rabbits, but it disappeared on the second day. - Other effects:
- In all the animals killed at the end of the test period , there were no significant changes in the upper or lower lids ,
nictitating membranes, eye balls , optic nerves or other organs.
Any other information on results incl. tables
In ocular response to DHT-4A undiluted, chief symptoms were conjunctival changes , whereas there were no changes in the cornea or iris.
1. Rabbits whose e yes were not washed
On the first day of eye - dropping, accelerated congestion of the conjunctiva was noted in two of the three rabbits,
while exaggerated conjunctival edema and excess discharge were observed in the other .
However, on the second day of eye-dropping , conjunctival congestion , edema and discharge began to disappear .
2. Rabbits whose eyes were washed 2 seconds after treatment.
On the first day of eye-dropping, excessive discharge was observed in two out of the three.
On the second day of eye-dropping , such disc harge began to cease.
3 . Rabbits whose eyes were washed 4 seconds after treatment .
On the first day of eye-dropping, accelerated conjunctival congestion was noticed in two of the three rabbits, but it disappeared on the second day.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information The very slight effects were fully reversible 48 hours after application. Criteria used for interpretation of results: EU
- Conclusions:
- This study of the primary stimulating effect of DHT- 4A on the ocular mucous membrane of the rabbit performed similar to OECD 405 guideline, indicated that DHT-4A showed very slight conjunctivae in 2 animals and very slight chemosis in one animal. The effects were fully reversible 48 hours after application.
- Executive summary:
This study of the primary stimulating effect of DHT- 4A on the ocular mucous membrane of the rabbit performed similar to OECD 405 guideline.
DHT-4A showed very slight conjunctivae in 2 animals and very slight chemosis in one animal. The effects were fully reversible 48 hours after application. Based on the results, DHT-4A does not have to be classified for eye irritation according to Regulation (EC) No 1272/2008.
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