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EC number: 836-285-0 | CAS number: 125349-37-3
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Oct - 14 Nov 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- GLP compliance unknown; deviations from guideline (3 instead of 4 animals / group, no information on positive control)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 Jul 2010
- Deviations:
- yes
- Remarks:
- - 3 instead of 4 animals/group - No information on positive control - No statistical analysis performed
- GLP compliance:
- not specified
- Remarks:
- in-house safety study
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (3R-)1,1,3-trimethylindan-4-amine
- EC Number:
- 836-285-0
- Cas Number:
- 125349-37-3
- Molecular formula:
- C12H17N
- IUPAC Name:
- (3R-)1,1,3-trimethylindan-4-amine
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JCrlj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 weeks (preliminary study); 11 weeks (main study 1); 8 weeks (main study 2)
- Weight at study initiation: preliminary study: 20.66 - 21.60 g; main study 1: 20.66 - 25.08 g; main study 2: 18.22 - 21.32 g
- Housing: The animals were housed in suspended stainless-steel cages comprising stainless-steel wire mesh front and floor, and aluminium walls (W 176 × D 302 × H 130 mm, Yamato Scientific Co., Ltd.), 3 animals per cage. Once a week, each cage was exchanged for a washed, sterilised cage.
- Diet: solid feed for mice (CRF-1, Oriental Yeast Co., Ltd.); ad libitum
- Water: tap water via an automatic water supply unit; ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): ≥ 10
- Photoperiod: 12 / 12
IN-LIFE DATES:
Preliminary study: 02 - 07 Oct 2013
Main study 1: 16 - 23 Oct 2013
Main study 2: 06 - 14 Nov 2013
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- preliminary study and main study 1: 5%, 25% (acetone/olive oil (4:1 v/v)), 100% (stock solution)
main study 2: 50% (acetone/olive oil (4:1 v/v)) - No. of animals per dose:
- preliminary study: 1 animal per concentration
main study 1 & 2: 3 animals per concentration and negative control - Details on study design:
- PRE-SCREEN TESTS
- Compound solubility: The test substance dissolved at 50% (v/v) in acetone/olive oil (4:1 v/v). Therefore, acetone/olive oil (4:1 v/v) was selected as the medium.
- Irritation: No irritation was observed after applying the test substance at any concentration.
- Lymph node weights: In the 5%, 25% and stock solution (100%) application groups the weights were 0.0046 g, 0.0063 g and 0.0061 g, respectively.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation
- Criteria used to consider a positive response: The ratios [radioactivity in the groups with the test substance applied (dpm) / radioactivity in the control group (dpm)] were calculated, and a ratio (stimulation index) of ≥ 3 was assessed as positive.
TREATMENT PREPARATION AND ADMINISTRATION
For the preliminary study, acetone/olive oil (4:1 v/v) solutions with the test substance at 5% and 25%, and the stock solution (100%) were applied, respectively, to both ears of the mice at 0.025 mL/site for 3 consecutive days (1 mouse / concentration). The presence/absence of irritation (erythema) was verified on days 2, 3 and 6, counting the first day of application as day 1. On day 6, the auricular lymph nodes were collected and weighed.
For main study 1, concentrations of the test substance were set to on the basis of the results of the preliminary study (5% and 25% acetone/olive oil (4:1 v/v), and stock solution (100%)) and were applied open to both ears of the mice at 0.025 mL/site for 3 consecutive days (3 mice / concentration). Also, a control group was established wherein only acetone/olive oil (4:1 v/v) was applied. The presence/absence of irritation (erythema) was verified on days 2, 3 and 6, counting the first day of application as day 1. On day 6, [methyl-3H]thymidine that had been prepared to a concentration of 2.96 MBq (80 µCi)/mL using PBS was administered intravenously at 0.25 mL/animal. 5 hours later, cells were harvested from the auricular lymph nodes, and the radioactivity (dpm) was measured using a liquid scintillation counter.
For main study 2, the treatment concentration was selected based on the results of main study 1 (50% acetone/olive oil (4:1 v/v)) and applied to both ears of each of the 3 mice at 0.025 mL/site on 3 consecutive days. Also, a control group was established wherein only acetone/olive oil (4:1 v/v) was applied. The presence/absence of irritation (erythema) was verified on days 2, 3 and 6, counting the first day of application as day 1. On day 6, [methyl-3H]thymidine that had been prepared to a concentration of 2.96 MBq (80 µCi)/mL using PBS was administered intravenously at 0.25 mL/animal; 5 hours later, cells were harvested from the auricular lymph nodes, and the radioactivity (dpm) was measured using a liquid scintillation counter. - Positive control substance(s):
- not specified
- Statistics:
- not performed
Results and discussion
- Positive control results:
- no data
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- > 25 - < 50
- Test group / Remarks:
- 50%
main study 2
- Key result
- Parameter:
- SI
- Value:
- 6.85
- Test group / Remarks:
- 50%
main study 2
- Key result
- Parameter:
- SI
- Value:
- 2.5
- Test group / Remarks:
- 25%
main study 1
- Key result
- Parameter:
- SI
- Value:
- 0.637
- Test group / Remarks:
- 5%
main study 1
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION:
Main study 1: The SI of the 5% and 25% treatment group was 0.637 and 2.5, respectively. The stock solution (100%) group was excluded from the study based on effects > 5% decrease in body weight of the animals, which was deemed unsuitable for evaluating sensitisation. The SI ratios were below 3, but due to the gap between the excluded high dose (100%) and the medium dose (25%), the study was performed again in a 50% application group (main study 2).
Main study 2: The SI of the 50% treatment group was 6.85.
EC3 CALCULATION:
The ratio was ≥ 3 in the 50% application group, and so the test substance was judged to be positive (25%
CLINICAL OBSERVATIONS
Main study 1: In the stock solution (100%) group, after completion of administration on day 2, decreased spontaneous movement and emaciation were observed in 1/3 animals. No irritation was observed at any concentration.
Main study 2: On day 3, very mild erythema was observed in 1/3 animals in the 50% application group. No clinical signs were noted.
BODY WEIGHTS:
Main study 1: Measuring the body weights in the stock solution (100%) group revealed a mean body weight decrease of 1.74 g. The mean body weight increases after test substance application in the control group, the 5% and 25% application groups were 1.24 g, 0.15 g and 1.83 g, respectively.
Main study 2: The mean body weight increases in the control group and the 50% application group were 1.31 g and 0.90 g, respectively.
LYMPH NODE WEIGHTS:
Main study 1: The mean lymph node weights in the control group and the 5% and 25% application groups were 0.0052 g, 0.0053 g and 0.0085 g, respectively.
Main study 2: The mean lymph node weights in the control group and the 50% application group were 0.0044 g and 0.0084 g, respectively.
Any other information on results incl. tables
Table 1: Results of main study 1
Dose (%) | Body weight (g) | Local reaction (ears)* | Lymph node weights (g) | Radioactivity | ||||||||
Day 1 | Day 6 | Weight increase | Mean weight increase | Day 2 | Day 3 | Day 6 | Individual | Group total | Group mean | Dpm | ratio | |
0# | 23.21 | 24.85 | 1.64 | 1.24 | 0 | 0 | 0 | 0.0041 | 0.0157 | 0.0052 | 1492 |
|
23.85 | 24.26 | 0.41 | 0 | 0 | 0 | 0.0066 | ||||||
22.76 | 24.43 | 1.67 | 0 | 0 | 0 | 0.0050 | ||||||
5a | 25.08 | 24.73 | -0.35 | -0.15 | 0 | 0 | 0 | 0.0051 | 0.0160 | 0.0053 | 950 | 0.637 |
25.00 | 25.43 | 0.43 | 0 | 0 | 0 | 0.0054 | ||||||
24.91 | 24.37 | -0.54 | 0 | 0 | 0 | 0.0055 | ||||||
25a | 24.26 | 26.76 | 2.50 | 1.83 | 0 | 0 | 0 | 0.0094 | 0.0255 | 0.0085 | 3730 | 2.50 |
22.78 | 23.67 | 0.89 | 0 | 0 | 0 | 0.0074 | ||||||
21.61 | 23.70 | 2.09 | 0 | 0 | 0 | 0.0087 | ||||||
100b | 20.66 | - | - | - | 0 | - | - | - | - | - | - | - |
24.32 | - | - | 0 | - | - | - | ||||||
24.10 | - | - | 0 | - | - | - |
#: Acetone/olive oil (4:1 v/v)
a Solution (acetone/olive oil (4:1 v/v) as medium) b Stock solution
*0: No erythema, 1: Very mild erythema, 2: Obvious erythema, 3: Moderate to severe erythema, 4: Severe erythema (beet redness) to slight crusting
Table 2: Results of main study 2
Dose (%) | Body weight (g) | Local reaction (ears)* | Lymph node weights (g) | Radioactivity | |||||||||
Day 1 | Day 6 | Weight increase | Mean weight increase | Day 2 | Day 3 | Day 6 | Individual | Group total | Group mean | Dpm | ratio | ||
0# | 18.22 | 19.87 | 1.65 | 1.31 | 0 | 0 | 0 | 0.0053 | 0.0133 | 0.0044 | 754 |
| |
21.05 | 22.50 | 1.45 | 0 | 0 | 0 | 0.0037 | |||||||
19.62 | 20.46 | 0.84 | 0 | 0 | 0 | 0.0043 | |||||||
50a | 18.25 | 19.81 | 1.56 | 0.90 | 0 | 0 | 0 | 0.0100 | 0.0253 | 0.0084 | 5163 | 6.85 | |
20.47 | 21.01 | 0.54 | 0 | 0 | 0 | 0.0074 | |||||||
21.32 | 21.92 | 0.60 | 0 | 0 | 0 | 0.0079 |
#: Acetone/olive oil (4:1 v/v)
a Solution (acetone/olive oil (4:1 v/v) as medium)
*0: No erythema, 1: Very mild erythema, 2: Obvious erythema, 3: Moderate to severe erythema, 4: Severe erythema (beet redness) to slight crusting
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sens 1B (H317) according to Regulation (EC) No 1272/2008.
- Conclusions:
- Under the present test conditions, the test substance (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine was assessed to be positive of exhibiting skin sensitising potential and meets the classification criteria Skin sens 1B (H317) according to Regulation (EC) No 1272/2008.
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