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EC number: 951-182-1 | 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Testing was carried out prior to REACH, OECD guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Study was carried our prior to REACH guidelines and GLP
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP
Test material
- Reference substance name:
- Diamino Trimethylphenylindane
- IUPAC Name:
- Diamino Trimethylphenylindane
- Test material form:
- solid: particulate/powder
- Details on test material:
- Purity:
97.6% (49.9% 6-4’ isomer, 47.7 5-4’ isomer; per Protocol)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young albino rabbits of the New Zealand strain were used in the evaluation
of the primary skin irritating properties of the test material. The test
procedure was modeled after that of Draize et al, *
Prior to the application of the test material, the hair was clipped from
the back and flanks of each rabbit. Two test sites located lateral to the midline
of the back approximately ten centimeters apart were selected. One of the
two sites was abraded by making four epidermal incisions, two perpendicular
to the other two, while the other test site remained intact.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Exactly 0.5 ml of undiluted test material (0.5 g of test material moistened
with a minimum amount of water in the case of solids) was applied to each of
the test sites on each rabbit. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Observations at 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- Prior to the application of the test material, the hair was clipped from
the back and flanks of each rabbit. Two test sites located lateral to the midline
of the back approximately ten centimeters apart were selected. One of the
two sites was abraded by making four epidermal incisions, two perpendicular
to the other two, while the other test site remained intact.
Exactly 0.5 ml of undiluted test material (0.5 g of test material moistened
with a minimum amount of water in the case of solids) was applied to each of
the test sites on each rabbit. The test sites were immediately occluded with
two-inch square gauze patches. The patches were placed directly over the
test sites and secured with masking tape. The trunk of each animal was then
wrapped with impervious plastic sheeting. The wrap held the patches in position
and retarded evaporation of the test material during the 24-hour exposure
period.
At the end of 24 hours, the plastic wrappings, patches, and all residual
test material were removed. The intact and abraded test sites were
examined and scored separately for erythema and edema on a graded scale of
0 to 4. After 72 hours, the sites were again examined and scored.
In evaluating the average irritation present, the mean scores f ulerythema
and edema of the intact test sites after 24 and 72 hours were added.
Similarly, the mean scores for erythema and edema of the abraded test sites
after 24 and 72 hours were added. These two values were totaled and divided
by four to obtain the mean primary irritation score.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
Any other information on results incl. tables
Animal Number | Abraded 24 hours Erythema |
Abraded 24 hours Edema |
Abraded 72 hours Erythema |
Abraded 72 hours Edema |
Intact Skin 24 hours Erythema |
Intact Skin 24 hours Edema |
Intact Skin 72 hours Erythema |
Intact Skin 72 hours Edema |
1 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 |
2 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 |
3 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 |
4 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 |
5 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
6 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Mean | 2.0 | 0.0 | 1.3 | 0.0 | 2.0 | 0.0 | 1.3 | 0.0 |
Subtotals: 3.3
Primiary Irritation Score 1.6
Erythema scores at 24 and 72 hours are probably due to mechanical
irritation during the removal of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Primiary Irritation Score 1.6 which is indicative of mild irritation.
- Executive summary:
Young albino rabbits of the New Zealand strain were used in the evaluation
of the primary skin irritating properties of the test material. The test
procedure was modeled after that of Draize et al.
Prior to the application of the test material, the hair was clipped from
the back and flanks of each rabbit. Two test sites located lateral to the midline
of the back approximately ten centimeters apart were selected. One of the
two sites was abraded by making four epidermal incisions, two perpendicular
to the other two, while the other test site remained intact.
Exactly 0.5 ml of undiluted test material (0.5 g of test material moistened
with a minimum amount of water in the case of solids) was applied to each of
the test sites on each rabbit. The test sites were immediately occluded with
two-inch square gauze patches. The patches were placed directly over the
test sites and secured with masking tape. The trunk of each animal was then
wrapped with impervious plastic sheeting. The wrap held the patches in position
and retarded evaporation of the test material during the 24-hour exposure
period.
At the end of 24 hours, the plastic wrappings, patches, and all residual
test material were removed. The intact and abraded test sites were
examined and scored separately for erythema and edema on a graded scale of
0 to 4. After 72 hours, the sites were again examined and scored.
In evaluating the average irritation present, the mean scores f ulerythema
and edema of the intact test sites after 24 and 72 hours were added.
Similarly, the mean scores for erythema and edema of the abraded test sites
after 24 and 72 hours were added. These two values were totaled and divided
by four to obtain the mean primary irritation score.
Draize, John H., Woodard, Geoffrey, and Calvery, Herbert O., "Methods
for the Study of Irritation and Toxicity of Substances Applied Topically to
the Skin and Mucous Membranes," J. Pharm. & Exp. Ther. 82, 377 (1944).
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