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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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A reasonable level of reporting, conducted to a good scientific standard.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Sixty female albino CD rats were divided into groups of 20 as control, 200 or 400 mg/kg bw/day of amipicillin anhydrate. The test material was incorporated into dry powdered food and adminsitered to male rats for four weeks prior to mating and to female rats, from two weeks prior to mating. The dose was gradually administered in food to acclimatise the animals to the bitter taste. Females were mated with males on a one to one basis. Females were dosed up to weaning for a total of at least 15 weeks. Pups were sacrificed periodically up to 1 month post weaning and examined for abnormalities.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ampicillin, anhydrous
- IUPAC Name:
- Ampicillin, anhydrous
- Details on test material:
- - Name of test material : Ampicillin, anhydrous (R-12, 101-5)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Housed individually
- Diet : ad libitum
- Water : ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature : 74-76 °F
- Humidity (%): 46-48%
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Fresh diet was prepared weekly - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: Sunday to Wednesday
- Proof of pregnancy: vaginal plug
- Further matings after two unsuccessful attempts: yes, females whose mating was not successful in the first period, were mated again the same way the following weeks until all became pregnant. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- At least 15 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Control (0), 200 and 400 mg/kg bw/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 20 females per dosing group.
- Control animals:
- yes, plain diet
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes - Litter observations:
- STANDARDISATION OF LITTERS
- Performed at postpartum
- If yes, maximum of 6 pups/litter 3 of each sex/litter as near as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical abnormalities
GROSS EXAMINATION OF DEAD PUPS:
possible cause of death was determined for pups born or found dead - Postmortem examinations (offspring):
- SACRIFICE
Animals not selected for further study were sacrificed by chloroform inhalation at parturition. Two were placed in alcohol, and the others in formalin. The pups placed in alcohol were processed by a modified Dawson's method with Alizarin red S staining for the study of bone malformations. Mortality of the pups was recorded twice, up to the first day and at weaning time. At weaning, pups were again examined carefully for gross malformations, weighed and measured. Two of each cage were left alive, the others were killed and the internal organs were examined. The surviving rats were killed one month later and checked again for gross malformations.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS) The weights of the females did not vary from the controls
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS) All the rats became pregnant in the first three mating cycles
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
Details on results (F1)
BODY WEIGHT (OFFSPRING) Weight and length of the pups were unaffected
GROSS PATHOLOGY (OFFSPRING) No morphological abnormalities occured during the course of the study.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 400 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Prenatal Toxicity of R-12.101-5 in Rats Oral Administration – Summary
Group |
No. of females mated |
No. of females with litter |
Average gestation period (days) |
No. of pups |
Average No. of pups/litter |
No. of abnormalities |
Mortality |
|||
Male |
Female |
Total |
Within 24 hours |
Up to weaning |
||||||
Control |
15 |
13 |
22.2 |
70 |
78 |
148 |
11.4 |
0 |
5 (1 eaten) |
3 |
200 mg/kg/day |
20 |
20 |
21.8 |
111 |
126 |
237 |
11.9 |
0 |
8 |
2 |
400 mg/kg/day |
20 |
18 |
21.7 |
113 |
104 |
217 |
12.0 |
0 |
7 (3 eaten) |
2 (1 accident) |
Applicant's summary and conclusion
- Conclusions:
- No effects were noted in a one litter prenatal toxicity study in rats dosed with either 200 or 400 mg/kg bw/day of ampicillin anhydrous.
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