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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-11-22 - 1991-04-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 84/449/EEC of 25 April 1984
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- 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-AMinopenicillansäure
- Physical state: solid
- Analytical purity: 97.4%
- Lot/batch No.: 222704E
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean weight: 183g (males), 171g (females)
- Housing: 5 animals in type III Makrolon cages
- Diet (e.g. ad libitum): Altromin 1324 pellets, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2°C
- Humidity (%): 50 ±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22.11.1990 To: 06.12.1990
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw - Doses:
- limit dose: 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at least twice daily
- Frequency of weighing: just before application, 7 and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the 14 day observation period.
- Clinical signs:
- other: Piloerection was observed from 1h after treatment up to day 6. One female showed a reduced general condition.
- Gross pathology:
- No abnormlities were detected.
Any other information on results incl. tables
Table 1: Body weights of male and female Wistar rats treated orally with 6-aminopenicillanic acid:
Animal No. |
Day 1 |
Day 8 |
Day 15 |
Males |
|||
1 |
176 |
215 |
240 |
2 |
186 |
233 |
268 |
3 |
187 |
228 |
262 |
4 |
184 |
232 |
260 |
5 |
180 |
222 |
265 |
Mean |
183 |
226 |
259 |
Females |
|||
1 |
173 |
197 |
200 |
2 |
175 |
197 |
205 |
3 |
173 |
191 |
192 |
4 |
169 |
184 |
190 |
5 |
166 |
184 |
187 |
Mean |
171 |
191 |
195 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The LD50 (rat oral) of 6-aminopenicillanic acid is greater than 2000 mg/kg bw.
- Executive summary:
The test substance 6-aminopenicillanic acid was administered to male and female Wistar rats by gavage. The experiment was performed as limit test with a concentration of 2000 mg/kg bw.
No animal died during the 14 day observation period. No abnormalities were detected regarding body weight development or gross pathology. Clinical signs attributed to test item administration was piloerection.
The LD50 was determined to be greater than 2000 mg/kg bw.
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