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Registration Dossier
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Diss Factsheets
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EC number: 617-560-2 | CAS number: 84377-83-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guinea pig topical sensitisation test
- GLP compliance:
- no
- Type of study:
- other: guinea pig topical sensitisation test
- Justification for non-LLNA method:
- Study was carried out before LLNA was considered a requirement. It is considered sufficient for the endpoint, so there was no need for an additional LLNA study, which would involve more animals.
Test material
- Reference substance name:
- 1-{[(6R,7R)-7-[(2Z)-2-({[1-(tert-butoxy)-2-methyl-1-oxopropan-2-yl]oxy}imino)-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}pyridin-1-ium
- EC Number:
- 617-560-2
- Cas Number:
- 84377-83-3
- Molecular formula:
- C45H44O7S2.5/2(C3H7NO)
- IUPAC Name:
- 1-{[(6R,7R)-7-[(2Z)-2-({[1-(tert-butoxy)-2-methyl-1-oxopropan-2-yl]oxy}imino)-2-{2-[(triphenylmethyl)amino]-1,3-thiazol-4-yl}acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}pyridin-1-ium
- Reference substance name:
- N,N-dimethylformamide
- EC Number:
- 200-679-5
- EC Name:
- N,N-dimethylformamide
- Cas Number:
- 68-12-2
- Molecular formula:
- C3H7NO
- IUPAC Name:
- N,N-dimethylformamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Moisture content 0.16% w/w (Karl FIscher) as supplied to laboratory.
Batch Number: G309569
Constituent 1
additive 1
- Specific details on test material used for the study:
- Batch No: RJ1173
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Five male and five female guinea pigs, initially weighing 250-300 g.
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: epicutaneous, no other information mentioned
- Vehicle:
- other: saline:2-methoxyethanol:Tween 80 (45:45:10)
- Concentration / amount:
- not mentioned
- Day(s)/duration:
- not mentioned
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: epicutaneous, not specified
- Vehicle:
- other: saline:2-methoxyethanol:Tween 80 (45:45:10)
- Concentration / amount:
- Not specified
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5
- Positive control substance(s):
- yes
- Remarks:
- Benzyl penicillin
Results and discussion
- Positive control results:
- At 24 hours, only 2/9 animals treated with Benzyl Penicillin gave positive results. This increased to 5/9 animals at 48 hours. This is a low result for the positive control substance, as sensitisation usually occurs in >80% of the animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Not available
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Not available
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not available
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not available
- No. with + reactions:
- 5
- Total no. in group:
- 9
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Skin sensitising potential of 1132/4 DMF (CQ Intermediate) is low, but cannot be ignored.
Over 20% of the animals showed positive responses to the challenge after 48 hours, which is sufficient to classify the substance as a Skin Sensitiser Category 1, according to the criteria set for animal studies in section 3.4.2.2.4.1 of Annex I of the CLP Regulation. - Executive summary:
The skin sensitisation potential of 0/4 dihydrochloride dihydrate, 1132/4 DMF and 1132/4 bis hydrochloride was assessed in the guinea pig topical sensitisation test. The results indicate that repeated contact of the human skin with 0/4 dihydrochloride dihydrate might produce contact dermatitis. The contact allergenic potential of 1132/4 DMF although low, cannot be ignored, and that of 1132/4 bis hydrochloride, if any, is very low.
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.
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