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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 433-400-2 | CAS number: 4245-76-5
- 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:
- 1996-07-29 till 1996-09-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 433-400-2
- EC Name:
- -
- Cas Number:
- 4245-76-5
- Molecular formula:
- C2H6N4O2
- IUPAC Name:
- 1-Methyl-3-nitro-guanidine
- Reference substance name:
- N-methyl-N'-nitro-guanidine
- IUPAC Name:
- N-methyl-N'-nitro-guanidine
- Details on test material:
- - Name of test material (as cited in study report): CA 2342 A (Intermediate of CGA 293343)
- Substance type: intermediate
- Physical state: solid
- Analytical purity: 98%
- Purity test date: reanalysis date December 1997
- Lot/batch No.: P.601014
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Laboratory Animal Breeding Pharma Division, Stein / Switzerland
- Age at study initiation: no data
- Weight at study initiation: 330 to 421 g
- Housing: The animals were housed individually in Macrolon cages
- Diet (e.g. ad libitum): ad libitum standard guinea pig pellets - NAFAG 845
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal application: peanut oil; epidermal application: vaseline
- Concentration / amount:
- - Induction exposure: 5.0% CA 2342 A (Intermediate of CGA 293343)
- Challenge exposure : 50% CA 2342 A (Intermediate of CGA 293343)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal application: peanut oil; epidermal application: vaseline
- Concentration / amount:
- - Induction exposure: 5.0% CA 2342 A (Intermediate of CGA 293343)
- Challenge exposure : 50% CA 2342 A (Intermediate of CGA 293343)
- No. of animals per dose:
- The test was performed on a total of 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group,
respectively. - Details on study design:
- RANGE FINDING TESTS:
Intradermal Induction:
The concentration for intradermal injections was selected on account of the solubility of the test article in standard vehicles, the local irritant potency and the systemic tolerability of the test article in a pretest. The following concentrations of CA 2342 A were examined in pretest animals: 0.5, 1, 3 and 5% (wlv). Local reactions at the injection sites were examined 24 and 48 hours after duplicate intradermal injections.
Epidermal Applications (induction and challenge):
The concentration for the epidermal applications was selected on account of the primary irritation potential of the test article. The following concentrations of CA 2342 A were examined in pretest animals to determine the maximum subirritant concentration: 10, 30 and 50% (w/v). At least 7 days before application of CA 2342 A, two pairs of consecutive intradermal injections of an adjuvant saline/mixture were applied to the shaved neck of 2 guinea pigs. On each animal, 3 different concentrations of CA 2342 A were tested simultaneously on the left and right flank using Hilltop chambers. Naive skin site served as control. Occlusive dressing was applied for 24 hours. Skin responses were scored 24 and 48 hours after removal of the dressing according to the Draize scale.
MAIN STUDY
A. INDUCTION EXPOSURE
INTRADERMAL:
- No. of exposures: one intradermal injection
- Exposure period: 10 days
- Test group: - adjuvant/physiological saline mixture 1:1 (v/v)
- 5.0% CA 2342 A (Intermediate of CGA 293343) in peanut oil
- 5.0% CA 2342 A (Intermediate of CGA 293343) in the adjuvant/physiological saline mixture (w/v) and peanut oil (50%; w/v)
- Control group: - adjuvant/physiological saline mixture 1:l (v/v)
- peanut oil
- adjuvant/physiological saline mixture 1:1 (v/v) and peanut oil (50%; w/v)
- Site: on the left and right side of the shaved neck of the animals
- Frequency of applications: Three pairs of intradermal injections (0.1 ml per injection) were made consecutively in test and control group animals
EPIDERMAL:
- No. of exposures: one epidermal application
- Exposure period: 48 hours
- Test group: 50% CA 2342 A (Interned. of CGA 293343) in vaseline
- Control group: vaseline
- Site: neck of the animals
- Frequency of applications: Three pairs of intradermal injections (0.1 ml per injection) were made consecutively in test and control group animals
B. CHALLENGE EXPOSURE
- No. of exposures: one topical challenge exposure
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- Test groups: 50% CA 2342 A (Intermediate of CGA 293343) in vaseline
- Control group: vaseline only
- Site: The animals were tested on one flank with CA 2342 A (Intermediate of CGA 293343) in vaseline and on the other flank with the vehicle alone
- Concentrations: 50% CA 2342 A; occlusive dressing
- Evaluation (hr after challenge): The challenge reactions were scored 24 and 48 hours after removing the dressings - Challenge controls:
- no rechallenge
- Positive control substance(s):
- yes
- Remarks:
- mild to moderate sensitisers, such as mercaptobenzothiazole, benzocaine, hexyl cinnamic aldehyde or potassiumdichromate
Results and discussion
- Positive control results:
- The sensitivity of the guinea pig strain is checked twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole,
benzocaine, hexyl cinnamic aldehyde or potassiumdichromate. The results of the latest positive control test are presented in the study report.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% CA 2342 A
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% CA 2342 A. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% CA 2342 A
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% CA 2342 A. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the sensitization rate of 0%, which is below the threshold of significance (i.e. below 30%) set in Commission Directive 93/21/EEC (18th
adaptation to technical progress of Council Directive 67/548/EEC), classification of CA 2342 A (Intermediate of CGA 293343) as to its sensitising
properties is not required. This classification still applies to the recent versions of both UN-GHS and EU-GHS (CLP). - Executive summary:
A guinea pig maximisation test was initiated to determine sensitising properties of CA 2342 A (Intermediate of CGA 293343) after challenge exposure by skin contact. The procedure of Magnusson and Kligman for adjuvant tests was followed. Epidermal challenge of 10 male and 10 female guinea pigs (test groups) resulted in no positive responses in all guinea pigs after 24 hours and 48 hours, corresponding to a sensitisation rate of 0%. No irritant skin reactions were recorded for control animals. All animals survived to the scheduled sacrifice. Body weights were unaffected by the treatment.
Based on the sensitization rate of 0%, which is below the threshold of significance (i.e. below 30%) set in Commission Directive 93/21/EEC (18th adaptation to technical progress of Council Directive 67/548/EEC), classification of CA 2342 A (Intermediate of CGA 293343) as to its sensitising properties is not required. This classification also applies to the recent versions of both UN-GHS and EU-GHS (CLP).
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.