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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-967-0 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experiment start date - 03 March 1983; Experiment end date - 14 March 1983; Study completion date - 29 March 1983.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The observation period was 7 days instead of 14 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- EC Number:
- 289-660-0
- EC Name:
- 3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide
- Cas Number:
- 89959-98-8
- Molecular formula:
- C18H21N6.Br
- IUPAC Name:
- Reaction mass of 3-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide and 5-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide
Constituent 1
- Specific details on test material used for the study:
- Code No: FAT 31016/I
Batch No. RZ 3068/37
Stability: October 2012
Description; Powder
Test Article Received; 25 October 1982.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf
- Number and sex of animals used: 3 males
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2085 - 2150 g
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814 Tox, Gossau SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C,
- Humidity (%): 30 - 70 %
- Photoperiod: 12 hours light cycle day
- Air changes: approximately 15 air changes/h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males
- Details on study design:
- - Application of the Substance: Not less than 24 hours before treatment, on the back of experimental animal, an area was shaven of at least 6 cm², by means of an electrical clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but not irritating tape. The substance was moistened before application.
REMOVAL OF TEST SUBSTANCE
- Washing: not specified
Study evaluation
- Scoring of symptoms, and local reactions: After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following observation period.
- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
- Body weight: At beginning of acclimatisation and end of test
- Mortality: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 3.3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Other effects:
- The body weight development was in one animal only affected by the application of the test article.
No other reactions to treatment were recorded during the whole observation period.
Any other information on results incl. tables
Observations:
The scores obtained are presented in the below tables:
Erythema and eschar | ||||||
Animal | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | |
31 | 2 | 2 | 2 | 2 | 1 | |
32 | 2 | 2 | 2 | 2 | 2 | |
33 | 1 | 1 | 1 | 1 | 1 | |
Total | 5 | 5 | 5 | 5 | A = 20 | |
Avg score | 1.67 | 1.67 | 1.67 | 1.67 |
Oedema | ||||||
Animal | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | |
31 | 2 | 2 | 2 | 2 | 1 | |
32 | 2 | 2 | 2 | 2 | 2 | |
33 | 1 | 1 | 1 | 1 | 1 | |
Total | 5 | 5 | 5 | 5 | B = 20 | |
1.67 | 1.67 | 1.67 | 1.67 |
INDEX of skin irritation : A 20 + B 20 = 40 : 12 = 3.33
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 31016/I was considered as an irritant to the skin.
- Executive summary:
The irritation potential of FAT 31016/I was evaluated in a study conducted according to OECD Guideline 404. 3 male rabbits were used in this study. A gauze patch with 0.5 g of the test material was applied to the prepared skin of the rabbits for the exposure duration of 4 hours. The reactions of the skin were appraised upon removal during an observation period of 7 days. The sum of scores read after 1, 24, 48 and 72 hours for erythema and edema were summed up and divided by 12 to get the primary irritation index, which was calculated to be 3.33. The mean individual scores for erythema as well as edema (mean of scores recorded at 24, 48 and 72 hours) for all 3 animals were 1.67 each. Hence, the criteria of "mean value of ≥2.3 - ≤4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours", required for classification of the substance as irritant was not attained. However, till the end of observations (day 7), erythema as well as edema were found to be persistent. Hence taking a conservative approach, owing to the lack of details regarding the reversibility of skin reactions, the substance was concluded to be an irritant to the skin.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)