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Diss Factsheets
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EC number: 241-168-7 | CAS number: 17096-47-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to column 2 of REACH Annex VII, the study does not need to be conducted because an acute toxicity study by the dermal route is available for the test substance and does not indicate skin irritation up to 2 000 mg/kg body weight (limit dose test).
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 December 1991 - 18 December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Species tested was different from the preferred one and the number of animals used was higher than that specified in the Guideline.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The received test article was placed in a desiccator approximately 24 hours prior to administration. - Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Lab Animals, Wayne, NJ; Hazleton Research Products, Denver, PA; Buckshire Corporation, Perkasie, PA.
- Females nulliparous and non-pregnant: Not specified.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Male: 2072.0 g (SD = 109.89 g); Female: 2018.2 g (SD = 83.16 g)
- Fasting period before study: not specified.
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council. Waste material was removed twice weekly. Cages and feeders were sanitized every two weeks.
- Diet (e.g. ad libitum): Ad libitum. Purina Lab Rabbit Chow H.FR. Food was checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): Ad libitum. Drinking water (Fresh tap-water). Water was monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.
- Acclimation period: the animals were acclimatized for at least 5 days before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20ºC (±3ºC)
- Humidity (%): 30 to 70%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle.
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: Not specified.
- Type of wrap if used: A square gauze patch was placed on the animals to cover the dosed area. The animals were wrapped with rubber dam and an elastic bandage to retard evaporation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin sites were wiped with acetone and gauze.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were recorded daily through Day 14. Body weights were recorded at initiation and on Days 7 and 14.
- Necropsy of survivors performed: yes. At termination, gross pathological findings were recorded and reported. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality ocurred during the study.
- Clinical signs:
- other: No clinical signs were observed in any animal receiving the test chemical.
- Gross pathology:
- No visible lesions were observed in any animal at terminal necropsy.
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rabbits.
- Executive summary:
In a dermal limit test (GLP study), one group of 10 New Zealand White rabbits (five males and five females) was exposed to the test substance at 2000 mg/kg for an exposure period of 24 h. Animals were observed for clinical signs and mortality once daily for fourteen days. No mortality and no clinical signs were observed in any animal receiving the test chemical. There were no apparent effects on mean body weight throughout the study. No visible lesions were observed in any animal at terminal necropsy. Based upon these observations, the estimated acute dermal LD50 (combined sexes) was determined to be greater than 2000 mg/kg.
Table 1. Summary of Clinical Observations. N-Methyl-2 Nitratoethyl Nitramine
Clinical signs | Sex | Hours | Days | ||||||||||||
24 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
No signs | M | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
F | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
Table 2. Summary of mortality. N-Methyl-2 Nitratoethyl Nitramine
Dose (mg/kg) | Sex | Nº of rabbits | Days | Total mortality | ||||||||||||
2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||||
2000 | M | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/5 |
2000 | F | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/5 |
Table 3. Summary of Body Weights (g). N-Methyl-2 Nitratoethyl Nitramine
Animal Number | Sex | Initial | Day 7 | Final |
5521 | M | 2238 | 2244 | 2375 |
5522 | M | 2018 | 1932 | 1997 |
5523 | M | 2130 | 2098 | 2395 |
5524 | M | 1984 | 2046 | 2140 |
5525 | M | 1990 | 2073 | 2086 |
x | 2072.0 | 2078.6 | 2198.6 | |
S.D. | 109.89 | 112.16 | 177.80 | |
N | 5 | 5 | 5 | |
5526 | F | 2158 | 2115 | 2346 |
5527 | F | 1935 | 1967 | 2278 |
5528 | F | 2007 | 1948 | 2234 |
5529 | F | 2000 | 1928 | 2023 |
5530 | F | 1991 | 1801 | 1935 |
x | 2018.2 | 1951. 8 | 2163.2 | |
S.D. | 83.16 | 112.01 | 175.60 | |
N | 5 | 5 | 5 |
Table 4. Necropsy Observations (Incidence Values). N-Methyl-2 Nitratoethyl Nitramine
Observation | Interim Death Incidence |
Terminal Necropsy Incidence | ||
No visible lesions |
M | F | M | F |
- | - | 5 | 5 |
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
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