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Diss Factsheets
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EC number: 231-034-6 | CAS number: 7417-99-4
- 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)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 December 2017 - 01 January 2018
- 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:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)
- EC Number:
- 231-034-6
- EC Name:
- N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)
- Cas Number:
- 7417-99-4
- Molecular formula:
- C19H20N4O2
- IUPAC Name:
- N-[4-({4-[(aziridine-1-carbonyl)amino]phenyl}methyl)phenyl]aziridine-1-carboxamide
- Test material form:
- solid
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan: WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation, India
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 219.8 to 226.0 g
- Fasting period before study: No
- Housing: 3 females in polypropylene rat cages covered with stainless steel grid top. Autoclaved clean rice husk was used as the bedding material. Wooden blocks were provided as enrichment material.
- Diet (e.g. ad libitum): Ad libitum. Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA. The quality of feed is regularly monitored at Jai Research Foundation.
- Water (e.g. ad libitum): Ad libitum. UV sterilized water filtered through Reverse Osmosis water filtration system. The quality of water is regularly monitored at Jai Research Foundation.
- Acclimation period: 6 to 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 49 to 66%
- Air changes (per hr): At least 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06.00 to 18.00 h) and 12 hours darkness.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage: at least 10%
- Type of wrap if used: porous gauze dressing (not more than 8 ply) and a non-irritating tape (Medi tape 330 hypo-allergenic surgical tape)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton soaked in RO water (freshly collected)
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200, 1000 and 2000 mg/kg body weight
- Concentration (if solution): N/A
- Constant volume or concentration used: N/A
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- Range finding study: 200, 1000 and 2000 mg/kg body weight
Main study: 2000 mg/kg body weight - No. of animals per sex per dose:
- Range finding study: 1 female per dose
Main study: 2 females per dose - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxicity and mortality at 0.5, 2, 4 and 6 h post-dermal application on the day of dosing (day 0). Morbidity and mortality twice a day. Erythema and oedema were recorded at 24 h, 48 h and 72 h post patch removal. The clinical signs were recorded once a day. Individual body weight was recorded prior to dermal application on day 0 and on days 7 and 14 post dermal application.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical observations: evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects and central nervous system effects, behavioural pattern, somatomotor activity and observation of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed. Erythema and oedema was not evident at 24, 48 and 72 h post patch removal in all the rats.
- Gross pathology:
- The macroscopic examinations of the animals at the end of the study did not reveal treatment-related changes.
Any other information on results incl. tables
Table 1: Individual and Mean Body Weight (g) and Body Weight Change (%)
Dose (mg/kg body weight) |
Date and Time of Dosing |
Animal N° |
Volume of test itemApplied (mL) |
Body Weights (g) on Day |
Percent Body Weight Change on Day |
|||
0 |
7 |
14 |
7 |
14 |
||||
200 |
December 07, 2017 and 10:15 am |
1 |
43.96 |
219.8 |
235.0 |
250.3 |
6.9 |
13.9 |
1000 |
December 11, 2017 and 10:20 am |
2 |
226.0 |
226.0 |
232.9 |
236.3 |
3.1 |
4.6 |
2000 |
December 13, 2017 and 10:35 am |
3 |
451.8 |
225.9 |
226.9 |
232.0 |
0.4 |
2.7 |
December 15, 2017 and 10:40 am |
4 |
447.4 |
223.7 |
231.7 |
240.1 |
3.6 |
7.3 |
|
December 18, 2017 and 10:45 am |
5 |
441.0 |
220.5 |
210.0 |
212.1 |
-4.8 |
-3.8 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Remarks:
- EU criteria.
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats.
- Executive summary:
The acute dermal toxicity of the test item was studied according to OECD 402 (GLP study). 5 female Wistar rats were tested for a exposure period of 24 h. Initially, a range finding study was conducted sequentially at doses of 200, 1000 and 2000 mg/kg bw in one animal per dose. Based on the results of range finding two additional rats were tested sequentially at a dose of 2000 mg/kg bw. At the end of the 24 h exposure period, the residual test item was removed with cotton soaked in RO water.The skin reactions of each rats were observed at 24, 48 and 72 h post patch removal.The rats were observed for a period of 14 days. There were no treatment-related mortality, clinical signs or necropsy findings recorded. Body weight gain was normal for all rats except for one rat whose body weight decreased on days 7 and 14 compared to day 0 but increased from day 7 to 14. Erythema and oedema was not evident at 24, 48 and 72 h post patch removal in all the rats. Based on the results of the study, the test item was found to be non toxic, with an LD50 > 2000 mg/kg bw.
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