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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- The primary skin-stimulation effect of DHT-4A in rabbits was investigated according to 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
- Species:
- rabbit
- Strain:
- other: white male Japanese rabbits (Yugengaisha Ichikaway)
- Details on test animals or test system and environmental conditions:
- Six healthy white male Japanese rabbits, weighing approximately 3 Kg (2.55-3.12kg), were used in this study. Solid food manufactured by Clea Japan Inc. (CR-1) and normal drinking water in a bottle were taken ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved excoriated and unexcoriated sites
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- The test drug, 500 mg, undiluted or its 10% solution, 0.5 mL, on a 4x4 cm lint patch was fixed tightly to the skin at 4 sites of each rabbit.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- Further observations and evaluation were made at the 48th and 72nd hours, as well as on the 5th and 7th day.
- Number of animals:
- 6
- Details on study design:
- The experiment was carried out as follows:
(a) Six rabbits were seared on the back , where 4 sites, larger than 5 x Scm each, were tested .
(b) Two diagonal sites of the four were scored in across -hatched pattern with a sterilized wire brush for destruct ion of the corneum. The injury was slight lest the corium should be impaired or bleeding should occur.
(c) The skin of two other sites was not excoriated.
(d) The test drug , 500mg , undiluted or i ts 10% solution, 0.5 ml , on a 4 x 4cm lint patch, wa s fixed tightly to the skin at the 4 sites of each rabbit .
(e) After a 24 -hours, the patches were removed and evaluation was made; thereafter, the sites were cleansed with water.
(f) Further observation and evaluation were made at the 48th and 72nd hours, as well as on the 5th and 7th days.
(g) The primary stimulating rate was calculated as a mean o f erythema and edema scores at 12 sites - 6 excoriated and 7 intact - at the 24th and
72th hours.
(h) After prognostic observation was made up to the 7th day, all animals were killed and the subcutaneous tissue under the testsites examined ;
the skin was then removed and fixed in a formalin solution for preservation .
Judgement of Results:
The results were graded according to Draize's rating scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Undiluted on excoriated site
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Undiluted on excoriated site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Undiluted on unexcoriated site
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Undiluted on unexcoriated site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 10% dilution on excoriated site
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 10% dilution on excoriated site
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 10% dilution on excoriated site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 10% dilution on unexcoriated site
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 10% dilution on unexcoriated site
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2, #3, #4, #5 and #6
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 10% dilution on unexcoriated site
- Irritant / corrosive response data:
- Experimental Results
The skin findings attributable to DHT-4A undiluted or to its 10% solution , chiefly involved edema.
1. A 10% DHT-4A Solution
1) Unexcoriated sites
No significant change was observed, except very slight edema in one of the six cases at the 24th hour of treatment.
The edema disappeared 48 hours after the solution was applied.
2) Excoriated sites
Except for very slight edema in 5 of the six cases at the 24th hour o f treatment, no particular change was noted .
The edema cleared up 48 hours a fter the solution was applied.
2. DHT- 4A Undiluted
1) Unexcoriated sites
After the 24th and 48th hours of application , neither erythema nor edema was seen , and no abnormal findings were noted .
2 ) Excoriated sites
There were no particular changes other than very slight edema observed in any cases 24 hours a fter application .
The edema cleared up 48 hours after application. - Other effects:
- In the animals killed at the end of the trial period, no abnormal findings were noted on the subcutaneous tissue under the test sites, or in any organ.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This study of the primary skin-stimulating effects of DHT- 4A undiluted and 10% DHT-4A performed similar to OECD 404 guideline, indicated that DHT-4A (undiluted and 10% dilution) showed only very slight edema 24 hours after application, even at excoriated sites. The edema effects were fully reversible 48 hours after application.
- Executive summary:
This study of the primary skin-stimulating effects of DHT- 4A undiluted and 10% DHT-4A using 6 male rabbits was performed similar to OECD 404 guideline.
DHT-4A (undiluted and 10% dilution) showed only very slight edema 24 hours after application. The edema effects were fully reversible 48 hours after application, even at excoriated sites.
In the animals killed at the end of the study, no abnormal findings were noted on the subcutaneous tissue under the test sites, or in any organ. Based on the results, DHT-4A does not have to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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