Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January to July 2000
- 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 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Taking effects as from 22nd September 1999, until 21st June 2000
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of study completion (2000), the LLNA OECD test method was not adopted.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS: Hartley Crl: (HA) BR, Caesarian obtained, Barrier sustained - Virus Antibody Free (COBS - VAF®)
- Source: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France
- Age at study initiation: approximately 3 months old
- Weight at study initiation: M: 369 ± 20 g; F: 369 ± 12 g
- Housing: individually in polycarbonate cages equipped with polypropylene bottle.
- Diet (e.g. ad libitum): free access to "106 pelleted diet" (UAR, 91360 Villemoisson-sur-Orge, France). Contaminants-free.
- Water (e.g. ad libitum):drinking water filtered by a FG Millipore membrane (0.22 µm) ad libitum. Contaminants-free.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): approximately 12 cyles/hour of filtered non-recycled air.
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2000-03-02 To: 2000-04-03
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 1 % w/w
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% w/w
- Day(s)/duration:
- D8 / 48 hrs
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % w/w
- Day(s)/duration:
- D22 / 24 hrs
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 2 preliminary/sex, 10 treated/sex, 5 control/sex
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal injections: 75, 50, 25, 10, 5 and 1 % (w/w); 2 animals/sex. The concentration chosen for the main study was 1% w/w (concentration well-tolerated systemically and locally, intradermal injections cause moderate irritant effects but no necrosis or ulceration of the skin).
- Topical application: 100 and 50 % (w/w); 1 animal / sex. The concentration chosen for the topical application of the induction phase and for the challenge application was 100% (concentration well-tolerated systemically and locally, cutaneous application for the induction should cause at most weak or moderate skin reactions or to be the maximal practicable concentration, cutaneous application for the challenge phase should be the highest concentration which does not cause irritant effects).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, intradermal injections + topical application
- Exposure period: 48 hours for topical application
- Test groups:
INTRADERMAL: 3 pairs of intradermal injection (0.1 mL) on Day 1 as follows:
- 1/ FCA 50% (v/v) in 0.9% NaCl
- 2/ test substance 1% in corn oil
- 3/ test substance 1% in 50:50 FCA/0.9% NaCl
TOPICAL: On Day 7, the same region received a topical application of sodium lauryl sulfate in vaseline (10% w/w), in order to induce local irritation. On Day 8, a pad of filter paper (approximately 8 cm²) was fully-loaded with the undiluted test substance and was then applied to the intrascapular region of the animals of the treated group. The pad was held in place for 48 hours by means of an adhesive hypoallergenic dressing and an adhesive analergenic waterproof plaster.
- Control group: similarly treated with the exception that corn oil was topically applied instead of the test substance.
- Site: intrascapular area
- Other: the presence of cutaneous irritation was checked on Day 10, after removal of the dressings of the cutaneous application.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Test groups: The animals of treated group received an application of the test substance and vehicle. The filter paper of a chamber (Finn Chamber®) was fully-loaded with the undiluted test substance and was then applied to a clipped area of the skin of the posterior right flank of all animals). The vehicle was applied under the same experimental conditions to the skin of the posterior left flank. the chambers were held in contact with the skin for 24 hours by means of an adhesive analergenic waterproof plaster.
- Control group: similarly treated
- Site: right and left flank
- Concentrations: 100 %
- Evaluation (hr after challenge): approximately 48 and 72 hours (24 and 48 hours after removal of the dressing) - Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole (recent reliability check)
Study design: in vivo (LLNA)
- Positive control substance(s):
- mercaptobenzothiazole (CAS No 149-30-4)
Results and discussion
- Positive control results:
- In a recent study (December 1999) performed under CIT experimental conditions, Mercaptobenzothiazole at the concentration of 20 % (w/w) induced positive skin sensitization in 80% guinea pigs, showing the sensitivity and reliability of the experimental technique.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema (score 1) in 8/20 animals, moderate erythema (score 2) in 5/20 animals
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema in 3/20 animals, moderate erythema in 7/20 animals, dryness of the skin in 14/20 animals and crusts in 1/20 animals
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 1 male with discrete erythema and dryness of the skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 1 male with discrete erythema and dryness of the skin.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Yellow coloration. 2 animals with score 1, 6 with score 2, 2 with score 3
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 20%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: Yellow coloration. 2 animals with score 1, 6 with score 2, 2 with score 3 .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Yellow coloration of the skin. 2 animals with score 0, 3 with score 2, other scorings masked by dryness of the skin
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 20%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: Yellow coloration of the skin. 2 animals with score 0, 3 with score 2, other scorings masked by dryness of the skin.
Any other information on results incl. tables
No clinical signs and no deaths were observed during the study. The body weight gain of the treated animals was similar to that of the control animals.
On Day 2, 24 hours after the intradermal injections and on Day 10, after removal of the dressings of the cutaneous application, signs of irritation were observed at the treatment site in the animals of the control and treated groups.
On removal of the challenge dressing, no residual test substance was observed.
In the control group, only a discrete (grade 1) erythema, associated with dryness of the skin, was observed at the 48 -hour reading in 1/10 animals.
In the treated group, a discrete erythema was noted in 8/20 animals at the 24 -hour reading and in 3/20 animals at the 48 -hour reading; a moderate erythema (score 2) was obseved in 5/20 animals at the 24 -hour reading and in 7/20 animals at the 48 -hour reading.
At the 48 -hour reading, dryness of the skin was observed in 14/20 animals and crusts were noted in 1/20 animals.
The moderate cutaneous reactions observed in 7/20 (35%) of animals of the treated group, which were of higher incidence and severity than those recorded in the animals of the control group, were attributed to delayed contact hypersensitivity.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the overall sensitisation rate (35%), the test material is classified as skin sensitiser Category 1B according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal sensitisation study performed according to the OECD test method No. 406 and in compliance with GLP, the test material was tested in male and female Hartley guinea-pigs using the Guinea-Pig Maximisation Test method (20 treated animals + 10 controls).
The preliminary study determined the concentration to be used for the induction and challenge phases of the main study.
The test material diluted in corn oil at 1 %( w/w) was administered by injection for intradermal induction. On Day 7, the animals received a topical application of sodium lauryl sulfate in vaseline (10% w/w), in order to induce local irritation. On Day 8, topical induction was performed with the test material as supplied. For the challenge, on Day 22, the test material was tested undiluted.
During a recent reliability check performed at CIT, 80% of the animals gave positive response to both challenge concentrations of the positive control, Mercaptobenzothiazole, at both the 48- and 72-hour examinations. The experimental technique used was therefore considered to be valid.
There were no responses apparent in the control group
No clinical signs and no deaths were noted during the study. The body weight gain of the treated animals was similar to that of the control animals.
After the challenge application, only a discrete (grade 1) erythema, associated with dryness of the skin, was observed at the 48 -hour reading in 1/10 animals in the control group.
In the treated group, a discrete erythema was noted in 8/20 animals at the 24 -hour reading and in 3/20 animals at the 48 -hour reading; a moderate erythema (score 2) was obseved in 5/20 animals at the 24 -hour reading and in 7/20 animals at the 48 -hour reading.
At the 48 -hour reading, dryness of the skin was observed in 14/20 animals and crusts were noted in 1/20 animals.
The moderate cutaneous reactions observed in 7/20 (35%) of animals of the treated group, which were of higher incidence and severity than those recorded in the animals of the control group, were attributed to delayed contact hypersensitivity.
The overall sensitisation rate was 35 %.
Based on the overall sensitisation rate, the test material is classified as skin sensitizer
- H317: May cause an allergic skin reaction (Sub-Category 1B) according of the Regulation EC No. 1272/2008 (CLP).
- Sub-Category 1B according to the GHS.
This study is considered as acceptable and satisfies the requirement for the skin sensitisation endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.