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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1991 - December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Not specified in the test report.
Test material
- Reference substance name:
- 2-(methylnitroamino)ethyl nitrate
- EC Number:
- 241-168-7
- EC Name:
- 2-(methylnitroamino)ethyl nitrate
- Cas Number:
- 17096-47-8
- Molecular formula:
- C3H7N3O5
- IUPAC Name:
- methyl(nitro)[2-(nitrooxy)ethyl]amine
- Test material form:
- solid
Constituent 1
- 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 treated for dessication prior to administration in the definitive test.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BuckberG Lab Animals, Tomkins Cove, New York.
- Females (if applicable) nulliparous and non-pregnant: Not specified.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: test group: males: 366.7 (SD=15.72) g; females: 346.4 (SD=13.92) g
- Housing: Guinea pigs were housed individually in 1/2" stainless steel wire mesh 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 daily. Cages and feeders sanitized every two weeks.
- Diet (e.g. ad libitum): ad libitum. Purina Guinea Pig DietR. 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 (fresh tap water). Water was monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.
- Acclimation period: Minimum of 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3ºC,
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12-h dark/light cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 300 mg moistened with 0.3 mL distilled water.
- Day(s)/duration:
- 3 applications (once per week for 3 weeks) of 6 hours exposure each.
- Adequacy of induction:
- other: According to a dose range finding study, the test chemical was dosed as received (after dessication).
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 300 mg moistened with 0.3 mL distilled water.
- Day(s)/duration:
- 1 application of 6 hours
- Adequacy of challenge:
- other: According to a dose range finding study, the test chemical was dosed as received (after dessication).
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
4 previously unexposed animals were each exposed to 1.0, 10 and 50% of the test article in acetone and as received. The treated sites (left dorsal surface of each animal) were examined after dosing and scored at 24 hours for erythema according to a similar grading scale shown in paragraph 23 of OECD TG 406. No signs of erythema were observed at any treatment site. Therefore, the test article was dosed as received.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 x 6 hours
- Test groups: 1
- Control group: 1 negative and 1 positive control groups.
- Site: left dorsal surface
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 300 mg/site moistened with 0.3 mL distilled water.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1 negative and 1 positive control groups.
- Site: test and positive groups: left dorsal surface; negative group: distilled water on the left flank and test article on the right flank.
- Concentrations: 300 mg/site moistened with 0.3 mL distilled water.
- Evaluation (hr after challenge): 24 and 48 hours
- Challenge controls:
- The negative control animals (10 animals) were challenged with distilled water on the left flank and test article on the right flank.
- Positive control substance(s):
- yes
- Remarks:
- A concurrent positive control group consisting of 5 animals was treated with (0.3%) 1-chloro-2,4-dinitrobenzene (DNCB) in ethanol (80%).
Results and discussion
- Positive control results:
- No to severe erythema with/without edema was observed in the positive control animals during the induction. A positive response was elicited in the animals challenged with the positive control article. More details are shown in the table below.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 300 mg/site moistened with 0.3 mL distilled water.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 300 mg/site moistened with 0.3 mL distilled water.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 300 mg/site moistened with 0.3 mL distilled water (test chemical on right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 300 mg/site moistened with 0.3 mL distilled water (test chemical on right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 2: Individual animal scores
Induction | Challenge | |||||||||||
week | 1 | 2 | 3 | 5 | ||||||||
Reading (hrs.) | 24 | 48 | 24 | 48 | 24 | 48 | 24 | 48 | ||||
Animal no. | Sex | |||||||||||
Me-NENA | 3801 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3802 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3803 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3804 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3805 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3806 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3807 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3808 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3809 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3810 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3811 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3812 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3813 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3814 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3815 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3816 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3817 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3818 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3819 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3820 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Positive control |
3831 | M | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 2 | ||
3832 | M | 0 | 0 | + | + | 2 | 3 | 2 | 1 | |||
3833 | M | 1 | 1 | + | 0 | 1 | 2 | 3 | 2 | |||
3834 | F | 1 | 1 | + | + | 2 | 1 | 2 | 2 | |||
3835 | F | 0 | 0 | + | + | 3 | 3 | 3 | 3 | |||
L | R | L | R | |||||||||
Negative control (distilled water) |
3821 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3822 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3823 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3824 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3825 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3826 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3827 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3828 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3829 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3830 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
L - Left flank (distilled water)
R == Right flank (MeNENA)
Table 3: Incidence and Severity of Responses at Challenge
Study Number | Challenge (Naive site) | |||
24 hours | 48 hours | |||
Incidence | Severity | Incidence | Severity | |
Me-NENA | 0/20 | 0.0 | 0/20 | 0.0 |
Negative control- Me-NENA |
0/10 | 0.0 | 0/10 | 0.0 |
Distilled water |
0/10 | 0.0 | 0/10 | 0.0 |
Positive control |
5/5 | 2.6 | 5/5 | 2.0 |
Table 4. Summary of Body Weights (g)
Test group | |||
Animal Number | Sex | Initial | Final |
3801 | M | 357 | 583 |
3802 | M | 372 | 651 |
3803 | M | 393 | 670 |
3804 | M | 387 | 627 |
3805 | M | 373 | 619 |
3806 | M | 341 | 566 |
3807 | M | 353 | 560 |
3808 | M | 371 | 615 |
3809 | M | 361 | 628 |
3810 | M | 359 | 607 |
x | 366.7 | 612.6 | |
S.D. | 15.72 | 35.13 | |
N | 10 | 10 | |
3811 | F | 370 | 602 |
3812 | F | 350 | 551 |
3813 | F | 341 | 498 |
3814 | F | 336 | 465 |
3815 | F | 343 | 503 |
3816 | F | 359 | 523 |
3817 | F | 323 | 486 |
3818 | F | 334 | 476 |
3819 | F | 359 | 556 |
3820 | F | 349 | 498 |
x | 346.4 | 515.8 | |
S.D. | 13.92 | 42.41 | |
N | 10 | 10 |
Negative control | |||
Animal Number | Sex | Initial | Final |
3821 | M | 361 | 537 |
3822 | M | 348 | 567 |
3823 | M | 375 | 619 |
3824 | M | 364 | 600 |
3825 | M | 375 | 612 |
x | 364.6 | 587.0 | |
S.D. | 11.24 | 34.34 | |
N | 5 | 5 | |
3826 | F | 352 | 557 |
3827 | F | 356 | 551 |
3828 | F | 339 | 531 |
3829 | F | 327 | 434 |
3830 | F | 338 | 529 |
x | 342.4 | 520.4 | |
S.D. | 11.68 | 49.82 | |
N | 5 | 5 |
Positive control | |||
Animal Number | Sex | Initial | Final |
3831 | M | 364 | 530 |
3832 | M | 413 | 709 |
3833 | M | 348 | 525 |
x | 375.0 | 588.0 | |
S.D. | 33.87 | 104.82 | |
N | 3 | 3 | |
3834 | F | 351 | 553 |
3835 | F | 347 | 508 |
x | 349.0 | 535.5 | |
S.D. | 2.83 | 31.82 | |
N | 2 | 2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test substance did not cause dermal sensitization in guinea pigs under the conditions of this study.
- Executive summary:
The test substance was tested for delayed contact hypersensitivity in the Buehler Assay (GLP study). In a preliminary dose-range-finding study two male and two female Hartley guinea pigs were exposed to 1.0, 10 and 50% of the test material in acetone and as received. Based upon the results of this study, the test article was dosed as received (after previous dessication) at 300 mg/site moistened with 0.3 mL distilled water. For the induction first stage, three groups of Hartley guinea pigs received the test article (10 males and 10 females), the positive control 0.3% 1-chloro-2,4-dinitrobenzene (2 males and 3 females) and the negative control distilled water (5 males and 5 females), respectively, by topical application once per week for a total of three six-hour insult periods. Treated sites were examined and scored at 24 and 48 hours for erythema according to grading scale of 0 to 3 similar to that set out in paragraph 23, OECD TG 406. No signs of erythema were observed in the test article-treated or negative control animals. No to severe erythema with/without edema was observed in the positive control animals. 14 days after the last induction exposure, all animals were challenged (6 hours exposure at the same dose) at a previously untested site. A positive response was elicited in the animals treated with the positive control. No responses were observed in any test article-treated animal. No responses were observed in any control animal challenged with distilled water on the left flank and test article on the right flank. All animals gained weight and survived to study termination. Based upon these observations, it was concluded that the test substance did not cause dermal sensitization in guinea pigs under the conditions of this study.
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