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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 606-744-8 | CAS number: 213464-77-8
- 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:
- July 6 to July 9, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- IR5878
ISO common name: Orthosulfamuron
Batch number: FCF/T/159-99 (ex 20274/71)
Purity: 93.72 ± 1.05 %
In vitro test system
- Details on animal used as source of test system:
- Species and Strain: Male and Female New Zealand White rabbits
Age: 2 months
Body weight: 1.8 ÷ 2.3 kg
Housing: for the entire duration of the study the rabbits were kept in metal cages with stainless feeders.
Feed: diet “2 RB 15 GLP certificate” produced by Charles River Italia’s feed licensee Mucedola Srl, Settimo Milanese. The diet was supplemented by the Producer with vitamins and traces elements. The diet was available ad libitum to the animals. Water was distributed ad libitum to the animals. - Details on test system:
- Environmental conditions:
Temperature and humidity measured during the study were 19 ± 2°C and 55 ± 10%, respectively.
Light: artificial lighting with a 12-hour circadian cycle (07:00 – 19:00).
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 4 males and 2 females
Animal room controls were set to mantain temperature and relative humidity at 19C +/- 2 and 55% +/- 10 respectively. There were 15-20 air changes per hour. The room was iluminated by artifical lighting with a 12 hour circadian cycle. For the entire duration of the study the rabbits were kept in metal cages with stainless steel feeders. The cages were hung on multiple metal cage racks. The waste was periodically flushed away by a time-programmed siphon system from above.
Test system
- Preparation of test site:
- clipped
- Amount / concentration applied:
- 0.5g/site
- Duration of treatment / exposure:
- single application.
Exposure time 3 minutes, 1 hours (first rabbit) and 4 hours (all rabbits) - Observation period:
- treatment sites were examined for signs of erythema and edema immediately after the 3 minute and the 1 hour exposure period (first rabbit). These sites were also examined after 72 hours. After removal of the patch applied for 4 hours, animals were examined for erythema and edema and the responses scored at 30 minutes and 60 minutes and at 24, 48 and 72 hours after patch removal. Adjacent areas of untreated skin of each animal served as control for the test.
- Number of animals:
- 4 males and 2 females
- Details on study design:
- Approximately 24 hours before the test the fur was clipped from the trunk of the animals. Care was taken not to abrade the skin and only animals with intact skin were used.
0.5g of the test article were moistened with about 1mL of water and then applied to a small area (approximately 6cm2) of skin and covered with a gauze patch held in place with non-ittitating tape. The patch was loosely held in contact with the skin by a means of a suitable semocclusive dressing fur the duration of the exposure period. At the end of each exposure period residual test substance was removed with water without altering the existing response or the integrity of the epidermis.
Exposure followed a stepwise procedure: Firstly one rabbit was used and three treatment sites of the skin were prepared. On the first site the patch was applied for an exposure period of 1 hour on the second site. Since no gross reaction was observed the patch was applied for an exposure period of 4 hours on the third skin site. The test was completed using five additional animals each with one patch only, for a 4 hour exposure period.
Adjacent areas of untreated skin of each animal served as control for the test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 3 minutes
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No changes were seen at any of the skin evaluation of the test article application sites.
- Other effects:
- Neither mortality nor adverse general clinical modifications were seen during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit skin.
- Executive summary:
IR5878 was moistened with about 1 mL of water and then applied to a small area (approximately 6 cm2) of skin of New Zealand White rabbits (4 males and 2 females). 0.5 mg of IR5878 were applied to the skin of each animal and covered with a gauze patch, which was loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure periods: 3 minutes, 1 hour (first animal only) and 4 hours.
IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit 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)
Iako ECHA većinu materijala na ovim stranicama osigurava na vašem jeziku, dio ove stranice samo je na engleskom. Dodatne informacije o politici višejezičnosti ECHA-e.
Dobro došli na stranice ECHA-e Ove stranice ne podržavaju potpuno Internet Explorer 7 (i njegove ranije inačice). Preuzmite noviju inačicu Internet Explorera.
Na ovom portalu koristimo kolačiće kako bismo vam osigurali najbolje iskustvo njegova pregledavanja.
Saznajte više o tome kako upotrebljavamo kolačiće.