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Diss Factsheets
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EC number: 208-993-4 | CAS number: 551-16-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A GLP study, comparable to current guidelines with the exception of the observation period of 3 days rather than the required 14 days.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were observed for 3 days, rather than the 14 days standard.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6-Aminopenicillinic Acid
- IUPAC Name:
- 6-Aminopenicillinic Acid
- Reference substance name:
- 6-aminopenicillanic acid
- EC Number:
- 208-993-4
- EC Name:
- 6-aminopenicillanic acid
- Cas Number:
- 551-16-6
- Molecular formula:
- C8H12N2O3S
- IUPAC Name:
- 6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): 6-APA (6-Aminopenicillinic Acid)
- Substance type: White powder
- Physical state: Solid
- Analytical purity: No data
- Lot/batch No.: WCD3823
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Sex: Female
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.510-2.914 kg
- 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.
- Diet : Purina Lab Rabbit Chow (H.F.), checked daily and added or replaced as needed according to Standard Operating Procedure PH-113. Feeders were designed to reduce soiling, bridging and scattering.
- Water : Fresh tap water ad libitum.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21 °C
- Humidity (%): 40 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hour light cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved, and abraded and non-abraded skin
- Vehicle:
- other: test material was moistened with0.9% saline.
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 500 mg/test article site - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Caudal and rostral on each flank
- Area coverage: Approximately 6 cm^2
- Type of wrap if used: The test article was applied to a small area of skin and covered with a gauze patch and loosely held in contact with the skin by means of a suitable semi-occlusive dressing and non-irritating tape for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed with gauze and water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize Evaluation of Dermal Irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 min, 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, no effects observed
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 60 min, 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable, no effects observed.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 min, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, no effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60 min, 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, no effects observed
- Irritant / corrosive response data:
- No effects were observed
- Other effects:
- No effects were observed
Any other information on results incl. tables
Table 1: Observations/Post Treatment for 6-APA
Rabitt No. |
Sex |
60 minutes |
24 hours |
48 hours |
72 hours |
||||||||||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
||||||||||
|
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
|
3254 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3255 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3256 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
I = Intact sites A = Abraded sites |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based upon the observations made in the Primary Dermal Irritation Study in rabbits, 6-APA (6-Aminopenicillinic Acid), was determined not to be a dermal irritant.
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