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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A well documented GLP study which is comparable to current accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Sex : Male
- Weight at study initiation: 2.618-2.849 kg
- Housing:Rabbits are housed in cages sized in accordance
- Diet : Purina Lab Rabbit Chow (HF), 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 was available ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hour light cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.1 mL packed volume. Test material was ground to a fine powder and dosed as received. - Duration of treatment / exposure:
- Up to 72 hours
- Observation period (in vivo):
- Eyes were examined at 1, 24, 48 and 72 hours post treatment.
- Number of animals or in vitro replicates:
- 3 animals were included in the study.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing was performed
SCORING SYSTEM: Draize scores for primary eye irritation, and assessed using the modified Kay and Calandra system
TOOL USED TO ASSESS SCORE: Pen light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 12.7
- Max. score:
- 14
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- Positive ocular scores were observed at 1 hour after treatment. All ocular scores returned to normal at 72 hours post treatment. Please refer to tables 2 to 5 for tablulated results under section Remarks on results including tables and figures.
- Other effects:
- All animals exhibited an increase in body weight during the study (please refer to table 1 under section Remarks on results including tables and figures)
Any other information on results incl. tables
Table 1: Bodyweights pre- and post-dosing
Animal No. |
Sex |
Initial bodyweight (kg) |
Final bodyweight (kg) |
3264 |
M |
2.622 |
2.650 |
3265 |
M |
2.849 |
2.876 |
3266 |
M |
2.618 |
2.713 |
Table 2: Eye irritation scoring for animal 3264
|
|
Time after treatment (hr) |
||||
Pre dose |
1 hr |
24 hr |
48 hr |
72 hr |
||
Conjunctivae |
Redness score (a) |
0 |
3 |
0 |
0 |
0 |
Chemosis score (b) |
0 |
2 |
1 |
1 |
0 |
|
Discharge score (c) |
0 |
2 |
0 |
0 |
0 |
|
(a + b + c) x 2 = |
0 |
14 |
2 |
2 |
0 |
|
Iris |
Score (d) |
0 |
0 |
0 |
0 |
0 |
(d) x 5 = |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
Degree score (e) |
0 |
0 |
0 |
0 |
0 |
Area score (f) |
0 |
0 |
0 |
0 |
0 |
|
(e x f) x 5 = |
0 |
0 |
0 |
0 |
0 |
|
Total score = |
0 |
14 |
2 |
2 |
0 |
Table 3: Eye irritation scoring for animal 3265
|
|
Time after treatment (hr) |
||||
Pre dose |
1 hr |
24 hr |
48 hr |
72 hr |
||
Conjunctivae |
Redness score (a) |
0 |
3 |
0 |
0 |
0 |
Chemosis score (b) |
0 |
2 |
0 |
0 |
0 |
|
Discharge score (c) |
0 |
1 |
0 |
0 |
0 |
|
(a + b + c) x 2 = |
0 |
12 |
0 |
0 |
0 |
|
Iris |
Score (d) |
0 |
0 |
0 |
0 |
0 |
(d) x 5 = |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
Degree score (e) |
0 |
0 |
0 |
0 |
0 |
Area score (f) |
0 |
0 |
0 |
0 |
0 |
|
(e x f) x 5 = |
0 |
0 |
0 |
0 |
0 |
|
Total score = |
0 |
12 |
0 |
0 |
0 |
Table 4: Eye irritation scoring for animal 3266
|
|
Time after treatment (hr) |
||||
Pre dose |
1 hr |
24 hr |
48 hr |
72 hr |
||
Conjunctivae |
Redness score (a) |
0 |
2 |
0 |
0 |
0 |
Chemosis score (b) |
0 |
2 |
0 |
0 |
0 |
|
Discharge score (c) |
0 |
2 |
0 |
0 |
0 |
|
(a + b + c) x 2 = |
0 |
12 |
0 |
0 |
0 |
|
Iris |
Score (d) |
0 |
0 |
0 |
0 |
0 |
(d) x 5 = |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
Degree score (e) |
0 |
0 |
0 |
0 |
0 |
Area score (f) |
0 |
0 |
0 |
0 |
0 |
|
(e x f) x 5 = |
0 |
0 |
0 |
0 |
0 |
|
Total score = |
0 |
12 |
0 |
0 |
0 |
Table 5: Group scores
|
Time after treatment (hr) |
||||
Pre dose |
1 hr |
24 hr |
48 hr |
72 hr |
|
Total group score |
0 |
38 |
2 |
2 |
0 |
Group mean score |
0 |
12.7 |
0.7 |
0.7 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information: All effects were reversible within 72 hours.
- Conclusions:
- The test material was determined to be a mild irritant (class 4 in the Modified Kay and Calandra system). The maximum Group mean score was 12.7.
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