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EC number: 222-426-8 | CAS number: 3468-11-9
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-06-12 to 2017-07-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The test for acute dermal toxicity is performed on the rat. Although several mammalian species may be used, the rat is the preferred rodent species.
In the assessment and evaluation of the toxic characteristics of chemicals, the determination of acute dermal toxicity is useful where exposure by the dermal route is likely.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-imino-1H-isoindol-3-amine
- EC Number:
- 222-426-8
- EC Name:
- 1-imino-1H-isoindol-3-amine
- Cas Number:
- 3468-11-9
- Molecular formula:
- C8H7N3
- IUPAC Name:
- 1-imino-1H-isoindol-3-amine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female (non-pregnant and nulliparous)
Number of animals: 5 male and 5 female animals
Age at the beginning of the study: males: 11-12 weeks; females: 12-13 weeks
Body weight on the day of administration:Males: 276g - 304g; Females: 218g - 230g
Housing and Feeding Conditions:
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- Preparation of the Animals:
- The animals were marked individualy by tail painting
- Approx. 24 hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Only animals with healthy intact skin were used
- Prior to the application a detailed clinical observation was performed on all animals. Only healthy animals were used.
Application:
- The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface
- The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner
Dose Level:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal
Exposure Period:
- The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item was removed using aqua ad injectionem - Duration of exposure:
- 24 h
- Doses:
- a single dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Observation Period:
- All animals were observed for 14 days after dosing
Evaluation of Primary Skin Irritation:
- Signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404
Weight Assessment:
The animals were weighed on day 1 (prior to the application) and on days 8 and 15
Clinical Examination:
- A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose)
- As soon as symptoms were noticed they were recorded
- Thereafter the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded
- Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma
Pathology:
- At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw
- All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes
- In absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation
Evaluation of Results:
- Individual reactions of each animal were recorded at each time of observation
- Toxic response data were recorded by sex and dose level
- Nature, severity and duration of clinical observations were described
- The body weight changes were summarised in a tabular form
- Necropsy findings were described - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not applicable
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: skin irritation reported
- Sex:
- male
- Dose descriptor:
- other: dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Sex:
- female
- Dose descriptor:
- other: dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- The test item showed no mortality
- Clinical signs:
- other: No signs of systemic toxicity. Signs of local toxicity and irritation.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal
- Other findings:
- - Erythema grade 1 was observed in all male animals but no female animals
- Crust was observed in 4 of 5 male and all female animals
- Necrosis was observed in 3 of 5 male animals but in no female animals
- Necrosis was not reversible within the observation period
Any other information on results incl. tables
Absolute body weights in g and body weight gain in %
Animal No. / Sex | body weight gain (g) | % | ||
Day 1 | Day 8 | Day 15 | Day 1-15 | |
21/Male | 286 | 271 | 307 | 7 |
22/Male | 304 | 315 | 349 | 15 |
23/Male | 279 | 295 | 327 | 17 |
24/Male | 276 | 283 | 304 | 10 |
25/Male | 287 | 291 | 316 | 10 |
26/Female | 219 | 216 | 215 | -2 |
27/Female | 218 | 224 | 230 | 6 |
28/Female | 229 | 227 | 245 | 7 |
29/Female | 230 | 240 | 240 | 4 |
30/Female | 223 | 224 | 230 | 3 |
The effects on weight loss are a common observation for animals within this study type, mainly for female animals and might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded.
LD50Cut-Off
Dose (mg/kg bw) |
Number of Animals |
Number of Intercurrent Deaths |
LD50Cut-Off (mg/kg bw) |
||||
2000 |
5 males |
0 |
> 2000 |
||||
2000 |
5 females |
0 |
> 2000 |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal lethal dose of the test item after a single dermal administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat) > 2000 mg/kg bw.
- Executive summary:
In order to determine the potential acute dermal toxicity of the test item, an acute dermal study on the rat was performed according to OECD 402 and in compliance to GLP. Wistar rats (5 male and 5 female) were exposed for 24h to 2000 mg/kg bw test substance.
Single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with mortality but with signs of local toxicity and irritation were observed. Although weight loss effects were observed, especially with female animals, it is concluded that this is a common observation for this study type and that this is probably secondary to the dressing. Toxicological relevance of this finding cannot be clearly concluded.
In conclusion, the dermal LD50was determined to be > 2000 mg/kg body weight.
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