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EC number: 213-485-0 | CAS number: 957-68-6
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 31, 1994 - October 18, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study (OECD 404) with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- EC Number:
- 213-485-0
- EC Name:
- 3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Cas Number:
- 957-68-6
- Molecular formula:
- C10H12N2O5S
- IUPAC Name:
- (6R,7R)-3-[(acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 7-ACA
- Physical state: white powder
- Analytical purity: 95%-102% (HPLC)
- Impurities: 7-ACA 4.7%
- Batch No.: 3701586
- Expiration date of the batch: stable under conditions of storage
- Storage condition of test material: in a refrigerator in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals:
Supplier: Charles River Wiga GmbH, D-97633 Sulzfeld
Number ans sex: 3 females
Animal maintenance:
Room temperature: average of 19.5 °C
Relative humidity: average of 50 %
Air exchange: 12 per hour
Light: artificial light from 6 a.m. to 6 p.m.
Cages: individual caging in metal wire cages. Ehret GmbH, D-79312 Emmendingen, type KK 016R
Feed: Altromin 2023 diet for rabbits, ad libitum
Water: tap water from an automatical watering system, ad libitum
Identification: labelling with felt-tipped pen in the ear
Acclimatization: 6 days
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A cellulose patch with 0.5 g of the test substance, spread over an area of approximately 6x2 cm and soaked with 1.5 ml distilled water, was applied to the test site and held in place by fixing marginally with non irritating tape.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- Procedure: Hair was clipped on the dorsal area of the trunk one day before the application of the test substance. The test site was median on the dorsal thoracal region.
A cellulose patch with 0.5 g of the test substance, spread over an area of approximately 6x2 cm and soaked with 1.5 ml distilled water, was applied to the test site and held in place by fixing marginally with non irritating tape. The application site was covered by a dressing.
Access by the animal to the application site was prevented by a plastic collar.
The duration of exposure was 4 hours.
At the end of the exposure period the dressing, the tape with the patch and the collar were removed. Residual test substance was wiped off using wet cellulose tissue.
Clinical examination and scoring:
Animals were examined for erythema/eschar and oedema as well as for other local and systemic signs approximately 1, 24, 48 and 72 hours after patch removal.
No additional examinations were performed.
The skin was examined using a cold light source KL 1500 electronic.
Dermal irritation was scored and recorded.
General examinations: At all observation times the animals were examined for other than local changes.
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after patch removal
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Erythema/eschar: In all animals only scores of "0" were noted at reading times.
Oedema: In all animals only scores of "0" were noted at reading times.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the EC-guideline 91/325 a test substance is considered to cause dermal irritation ("R38"), if a mean score of "2.0" or more for erythema/eschar or for oedema formation (calculated from the reading times, i.e. 24, 48 and 72 hours after the end of exposure) is observed in at least 2/3 animals.
The following mean scores were calculated for the individual examinations:
Erythema/eschar: "0.0" in all animals.
Oedema: "0.0" in all animals.
Therefore, the test substance "7-ACA" does not require the risk phrase "R38 - Irritating to skin".
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