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EC number: 700-617-1 | 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
- Study period:
- October 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Taking effects as from 13th May 1998, until 29th January 2000
Test material
- Reference substance name:
- 3-(3,3-dimethyl-2,3-dihydro-1H-inden-5-yl)propanal
- Cas Number:
- 173445-65-3
- Molecular formula:
- C14H18O
- IUPAC Name:
- 3-(3,3-dimethyl-2,3-dihydro-1H-inden-5-yl)propanal
- Reference substance name:
- 3-(1,1-dimethyl-2,3-dihydro-1H-inden-5-yl)propanal
- Cas Number:
- 173445-44-8
- Molecular formula:
- C14H18O
- IUPAC Name:
- 3-(1,1-dimethyl-2,3-dihydro-1H-inden-5-yl)propanal
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): ST 22 C 99
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, protected from light and under nitrogen gas
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
- Age at study initiation: not reported
- Weight at study initiation: on the day of treatment, the animals had a mean body weight ± standard deviation of 2.5 ±0.3 kg.
- Housing: individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet (e.g. ad libitum): free access to 112 C pelleted diet (UAR, 91360 Villemoissonsur-Orge, France).
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by external laboratories.
No contaminants were known to have been present in the diet or drinicing water at levels which may be expected to have interfered with or prejudiced the outcome of the study.
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1999-10-06 To: 1999-10-13
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
A single dose of 0.5 ml of the undiluted test substance was applied to the closely-clipped skin of one flank. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examinations were done approximately 1 hour, 24, 48 and 72 hours after removal of the dressing, then daily up to reversibility (Day 8)
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: right flank
- Type of wrap if used: A single dose of 0.5 mL of the undiluted test substance was placed on a dry gauze pad, which was then applied to the right flank of the animals for 4 hours. The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not needed
SCORING SYSTEM:
Erythema and eschar formation:
0: - No erythema
1: - Very slight erythema (barely perceptible)
2: - Well defined erythema
3: - Moderate to severe erythema
4: - Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0: - No oedema
1: - Very slight oedema (barely perceptible)
2: - Slight oedema (edges of area well defined by definite raising)
3: - Moderate oedema (raised approximately 1 mm)
4: - Severe oedema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 120 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- A well-defined erythema (grade 2) was noted in all animals on day 1, then a very slight erythema (grade 1) was observed up to day 3, 4, or 5. Dryness of the skin was observed on days 5, 6 and 7 in animal#1. See Table 7.3.1/1.
- Other effects:
- none
Any other information on results incl. tables
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
2 / 2 / 2 |
0 / 0 / 0 |
24 h |
1 / 1 / 1 |
0 / 0 / 0 |
48 h |
1 / 1 / 1 |
0 / 0 / 0 |
72 h |
1 / 0 / 1 |
0 / 0 / 0 |
Average 24h, 48h, 72h |
1.0 / 0.67 / 1.0 |
0.0 / 0.0 / 0.0 |
Reversibility*) |
c. |
- |
Average time for reversion |
120 hours |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material induces a slight to well-defined erythema being reversible within 6 days. Therefore the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test material was applied on the clipped skin of the right flank of 3 males New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 hours after the removal of the patch and up to reversibility.
A well-defined erythema (grade 2) was noted in all animals on day 1, then a very slight erythema (grade 1) was observed up to day 3, 4, or 5. Dryness of the skin was recorded in one animal between day 5 and 7.
The individual scores for each animal within 3 scoring times (24, 48 and 72 hours) were 1.00 / 0.67 / 1.00 for erythema and 0.00 / 0.00 / 0.00 for oedema.
Therefore the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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