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EC number: 218-308-0 | CAS number: 2114-02-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-amidino-2-thiourea
- EC Number:
- 218-308-0
- EC Name:
- 1-amidino-2-thiourea
- Cas Number:
- 2114-02-5
- Molecular formula:
- C2H6N4S
- IUPAC Name:
- 1-(Diaminomethylidene)thiourea
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Supplier: Changzou Foreign Trade Corp.Batch No.: 0041A25 (20141211)Physical state: solid substance, crystalline powderColour: whiteStorage: in a cool, dry place, protected from light
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain: CBA/Ca Ola Hsd miceSource: TOXI-COOP ZRT.Hygienic level duringthe study: Good conventionalNumber of animals: 28 animals/main testSex: Female, nulliparous, non-pregnantAge of animals: Young adult mice;11-12 weeks old (at start of the main test)Body weight range at starting: 18.5-23.4 gThe weight variation in animals involved in the study did not exceed ± 20 % of the mean weight.Acclimatization time: 7 daysAnimal health: Only healthy animals were usedHousing during acclimatization period: Grouped caging in small groupsHousing during the test: Grouped caging (4 animals/cage)Cage type: Type II. Polypropylene / polycarbonateBedding: Laboratory beddingLight: 12 hours daily, from 6.00 a.m. to 6.00 p.m.Temperature: 22 ± 3 °CRelative humidity: 30 – 70 %Housing/Enrichment: Mice were group-housed to allow social interaction, and with deep wood sawdust bedding, to allow digging and other normal rodent activities.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Based on the preliminary test results the test item was examined in the main test at 25 %, 10 %, 5 % and 2.5 % (w/v) concentrations as formulations in N,N-Dimethylformamide (DMF).
- No. of animals per dose:
- 4 animals/treatment group
- Details on study design:
- Animals in the treatment groups were treated with the relevant vehicles (DMF or AOO), appropriate formulations of the test item or 25 % (w/v) concentration of the positive control substance. The test item was administered at four different concentrations according to the results of the dose range finding test. For detailed data see the table below.Each mouse was topically treated with 25 μL of the appropriate formulations of the test item, the positive control substance or the vehicles (see Table 3) using a pipette, on the dorsal surface of each ear. After the treatments animals were returned to their cages. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6.All animals have been monitored daily for systemic toxicity or excessive skin irritation. In case of failed treatment, systemic toxicity or excessive irritation the respective dose-group is excluded from evaluation.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control group animals were treated with 25 % (w/v) HCA solution (dissolved in AOO) concurrent to the test item groups. No mortality, cutaneous reactions or signs of toxicity were observed in the positive control group.Significant lymphoproliferative response (SI ≥ 3) was noted for HCA (SI = 6.9). The results of the positive control item demonstrated appropriate performance of the test in accordance with the relevant guidelines and confirmed validity of the assay.
In vivo (LLNA)
Results
- Remarks on result:
- other: no skin sensitization potential
Any other information on results incl. tables
Test GroupName | Measured DPM/group | Group* DPM | DPN (DPM/Node) | Stimulation IndexValues |
Vehicle control for the positive control: AOO | 8610 | 8585.0 | 1073.1 | 1.0 |
Positive control: | 59201 | 59176.0 | 7397.0 | 6.9 |
Amidinothiourea (CAS No. 2114-02-5) 25% in DMF | 16022 | 15997.0 | 1999.0 | 2.2 |
Amidinothiourea (CAS No. 2114-02-5) 10% in DMF | 3694 | 3669.0 | 458.6 | 0.5 |
Amidinothiourea (CAS No. 2114-02-5) 5% in DMF | 6502 | 6477.0 | 809.6 | 0.9 |
Amidinothiourea (CAS No. 2114-02-5) 2,5% in DMF | 7503 | 7478.0 | 934.8 | 1.0 |
Vehicle control for the test item: DMF | 7184 | 7159.0 | 894.9 | 1.0 |
*Group DPM = measured DPMgroup- average DPMbackground
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, under the conditions of the present Local Lymph Node Assay, AMIDINOTHIOUREA (CAS No. 2114-02-5) tested at the maximum attainable concentration of 25 % (based on solubility) and at concentrations of 10 %, 5% and 2.5 % (w/v) as formulations in an appropriate vehicle (DMF) was shown to have no skin sensitization potential.
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