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EC number: 838-724-1 | CAS number: 94568-76-0
- 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:
- 18 Jul - 01 Aug 2012
- 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, no clinical observations performed)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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 - no clinical observations performed
- GLP compliance:
- not specified
- Remarks:
- in-house safety study
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine
- EC Number:
- 838-724-1
- Cas Number:
- 94568-76-0
- Molecular formula:
- C12H17N
- IUPAC Name:
- 1,1,3-trimethyl-2,3-dihydro-1H-inden-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: 8 weeks (preliminary study); 9 weeks (main study)
- Weight at study initiation: preliminary study: 19.86 - 22.29 g; main study: 19.68 - 23.28 g
- Housing: housed 3 animals per cage in suspended cages with aluminum/stainless steel walls and stainless steel netting floor and front opening (W176 × D302 × H130 mm, Yamato Scientific Co., Ltd.); cages were exchanged for clean sterile cages once a week
- Diet: solid mouse chow (CRF-1, Oriental Yeast Co., Ltd.); ad libitum
- Water: tap water; ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): ≥ 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES:
Preliminary study: 18 - 23 Jul 2012
Main study: 25 Jul - 01 Aug 2012
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- preliminary study: 5%, 25%, 100%
main study: 1%, 5%, 25% - No. of animals per dose:
- preliminary study: 3 animals (one per dose group)
main study: 12 animals (3 per dose group 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 vehicle.
- Irritation: No irritation was observed after application at any concentration.
- Lymph node weights: 0.0045 g, 0.0085 g, and 0.0103 g in the 5%, 25% and 100% application groups, respectively
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine
- 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 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 undiluted substance (100%) were applied open to both ears of the mice at 0.025 mL/site for 3 consecutive days (1 mouse / concentration). The day that application was started was calculated as day 1 of the study, and the presence or absence of irritation (erythema) was confirmed on day 2, 3 and 6 of the study. In addition, on day 6 of the study the auricular lymph nodes were collected, and the weight was measured.
For the main study, concentrations of the test substance were set to on the basis of the results of the preliminary study (1%, 5% and 25% acetone/olive oil (4:1, v/v) solutions) and were applied open to both ears of the mice at 0.025 mL/site for 3 consecutive days (3 mice / concentration). In addition, there was a group to which acetone/olive oil (4:1 v/v) only was applied, as a control group. The day that application was started was calculated as day 1 of the study, and the presence or absence of irritation (erythema) was confirmed on days 2 and 3 of the study. On day 6 of the study, [methyl-3H]thymidine prepared to a concentration of 2.96 MBq (80 µCi)/mL by using PBS was administered intravenously at 0.25 mL/animal, and 5 hours after administration cells were recovered from auricular lymph nodes, and radiation (dpm) was measured by liquid scintillation counting. - 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:
- ca. 10
- Key result
- Parameter:
- SI
- Value:
- 6
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 1%
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION:
The SI of the 1%, 5% and 25% treatment group was 1.8, 1.4 and 6.0, respectively.
EC3 CALCULATION:
The EC3 was estimated to be ca. 10%.
CLINICAL OBSERVATIONS:
Not performed.
BODY WEIGHTS:
Body weight gain after application of the test substance averaged 0.81 g, 1.26 g, 1.81 g, and 0.49 g in the control group and the 1%, 5% and 25% application groups, respectively.
SIGNS OF TOXICITY:
No signs of irritation were noted at any concentration.
LYMPH NODE WEIGHTS:
In the control group and the 1%, 5% and 25% application groups, lymph node weights averaged 0.0045 g, 0.0053 g, 0.0054 g and 0.0077 g, respectively.
Any other information on results incl. tables
Table 1: Results of the skin sensitisation study
Dose (%)* | Body weight (g) | Irritation | Lymph node weight | Radioactivity | ||||||||
Study day 1 | Study day 6 | Weight gain | Average weight gain | Study day 2 | Study day 3 | Indi-vidual | Group total | Group average | dpm | ratio | ||
0 | 21.50 | 22.62 | 1.12 | 0.81 | No irritation | 0.0040 | 0.0134 | 0.0045 | 1146 | - | ||
20.39 | 20.63 | 0.24 | No irritation | 0.0045 | ||||||||
22.54 | 23.60 | 1.06 | No irritation | 0.0049 | ||||||||
1 | 22.14 | 22.94 | 0.80 | 1.26 | No irritation | 0.0057 | 0.0158 | 0.0053 | 2103 | 1.8 | ||
21.22 | 22.59 | 1.37 | No irritation | 0.0057 | ||||||||
22.13 | 23.74 | 1.61 | No irritation | 0.0044 | ||||||||
5 | 22.15 | 24.51 | 2.36 | 1.81 | No irritation | 0.0051 | 0.0162 | 0.0054 | 1633 | 1.4 | ||
23.28 | 24.74 | 1.46 | No irritation | 0.0059 | ||||||||
19.68 | 21.29 | 1.61 | No irritation | 0.0052 | ||||||||
25 | 22.90 | 22.74 | -0.16 | 0.49 | No irritation | 0.0085 | 0.0232 | 0.0077 | 6880 | 6.0 | ||
21.92 | 23.03 | 1.11 | No irritation | 0.0074 | ||||||||
21.35 | 21.86 | 0.51 | No irritation | 0.0073 |
* in acetone/olive oil (4/1 v/v); vehicle
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Sens.1B (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance 1,1,3-trimethylindan-4-amine 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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