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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 430-960-1 | 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21/03/2018 - 30/04/18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: EC No. 640/2012 Part B (Skin Sensitization: Local Lymph Node Assay) July 2012
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 430-960-1
- EC Name:
- -
- Molecular formula:
- C21H20N4O2
- IUPAC Name:
- Reaction mass of aniline and m-tolylidene diisocyanate
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks old
- Weight at study initiation: 19.0 - 24.4 g
- Housing: Group housed in groups of 5
- Diet (e.g. ad libitum): Pelleted rodent diet
- Water (e.g. ad libitum): Tap water freely available
- Acclimation period: 5 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 41-51
- Air changes (per hr): Ten or greater
- Photoperiod (hrs dark / hrs light): 12 hour light: 12 hour dark
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 2, 5, 10% w/w
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: 10%
- Irritation: Slight erythema
- Systemic toxicity: No signs
- Ear thickness measurements: Variation - 25%
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: SI > 3
TREATMENT PREPARATION AND ADMINISTRATION: Test item dosing formulations (w/w) were homogenised to visually acceptable levels at appropriate concentrations to meet dose level requirements. The dosing formulations were prepared daily and dosed within 4 hours after adding the vehicle to the test item. The dosing formulations were kept at room temperature until dosing.
The dorsal surface of both ears was topically treated (25 μL/ear) with the test item, at approximately the same time on each day. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Stimulation index (SI) calculated for each group using individual SI values
Results and discussion
- Positive control results:
- An EC3 value of 19.2% was calculated using linear interpolation.
The calculated EC3 value was found to be within the acceptable range of 4.8 and 19.5%.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Variability:
- 0.1
- Test group / Remarks:
- Control
- Remarks on result:
- other: Mean SI group value used
- Parameter:
- SI
- Value:
- 1.3
- Variability:
- 0.1
- Test group / Remarks:
- 2%
- Remarks on result:
- other: Mean SI group value used
- Parameter:
- SI
- Value:
- 1.2
- Variability:
- 0.2
- Test group / Remarks:
- 5%
- Remarks on result:
- other: Mean SI group value used
- Parameter:
- SI
- Value:
- 1.4
- Variability:
- 0.1
- Test group / Remarks:
- 10%
- Remarks on result:
- other: Mean SI group value used
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
: Individual SI is the ratio of the DPM/animal compared to the DPM/control group mean
CLINICAL OBSERVATIONS: No clinical signs of systemic toxicity
BODY WEIGHTS: Body weights remained in same range
Any other information on results incl. tables
group |
TS1 (%) |
animal |
Size nodes2 |
DPM3/ animal |
mean DPM ± SEM4 |
mean SI ± SEM |
|||||
left |
right |
||||||||||
|
|
|
|
|
|
|
|
||||
1 |
0 |
1 |
n |
n |
802 |
896 |
± |
117 |
1.0 |
± |
0.1 |
|
|
2 |
n |
n |
717 |
||||||
|
|
3 |
n |
n |
1151 |
||||||
|
|
4 |
n |
n |
1193 |
||||||
|
|
5 |
n |
n |
617 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
2 |
2 |
6 |
n |
n |
1232 |
1158 |
± |
132 |
1.3 |
± |
0.1 |
|
|
7 |
n |
n |
984 |
||||||
|
|
8 |
n |
n |
797 |
||||||
|
|
9 |
n |
n |
1586 |
||||||
|
|
10 |
n |
n |
1191 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
3 |
5 |
11 |
n |
n |
467 |
1110 |
± |
197 |
1.2 |
± |
0.2 |
|
|
12 |
n |
n |
1403 |
||||||
|
|
13 |
n |
n |
922 |
||||||
|
|
14 |
n |
n |
1603 |
||||||
|
|
15 |
n |
n |
1154 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
4 |
10 |
16 |
n |
n |
1256 |
1260 |
± |
129 |
1.4 |
± |
0.1 |
|
|
17 |
n |
n |
1316 |
||||||
|
|
18 |
n |
n |
1708 |
||||||
|
|
19 |
n |
n |
1068 |
||||||
|
|
20 |
n |
n |
954 |
||||||
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test item was determined not to be a skin sensitiser.
- Executive summary:
Three experimental groups of five female CBA/J mice were treated with test item concentrations of 2, 5 and 10% on three consecutive days by open application to the ears. Five vehicle control mice were also treated with the vehicle alone (dimethyl sulfoxide). Three days after the last exposure, all animals were injected with the 3H-methyl thymidine and after five hours the draining lymph nodes were excised and pooled for each animal. After precipitating the DNA of lymph node cells, radioactivity measurements were performed. The SI values calculated for the test item at concentrations of 2, 5 and 10% were 1.3, 1.2 and 1.4 respectively. There was no indication that the test item elicited a SI≥3 when tested up to 10%. Therefore, the test item was determined not to be a skin sensitiser.
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.