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EC number: 617-116-8 | CAS number: 80573-04-2
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline is specified in the report
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Cas Number:
- 150399-21-6
- Molecular formula:
- C17H13N3O6Na2 . 2H2O
- IUPAC Name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 18 - 26 weeks old
- Weight at study initiation: 3.31 - 5.04 kg
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- The volume of administration was fixed at 10 mL/kg bw.
- Duration of treatment / exposure:
- Day 6 - 19 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- Up to day 29 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 120 mg/kg bw/day
- Dose / conc.:
- 600 mg/kg bw/day
- Dose / conc.:
- 1 200 mg/kg bw/day
- No. of animals per sex per dose:
- 15 pregnant females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The selection of the doses were based on a preliminary teratology study in rabbits in which oral doses of 500, 1000 and 2000 mg/kg bw/day were used. Pregnant rabbits were treated from day 6 - 19 of gestation. Increased incidence of reduced or loose faeces were seen in mid and high dose treated rabbits. One high dose treated rabbit was found dead and the cause of death was most likely drug related. Additionally, one high dose treated female aborted during the study period. During the treatment period, body weights were decreased by 82% along with about 42% reduction in food consumptions in high dose treated females. No treatment related effects were seen at necropsy (day 29 of gestation). Based on these results the Sponsor selected 1200 mg/kg bw/day as the highest dose for the main study.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Daily
FOOD CONSUMPTION: Yes
- Time schedule: Days 1-5, 6-12, 13-19, 20-23 and 24-28
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined:
OTHER: Histopathology was performed on all the rabbits that died during the study. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No data
- Skeletal examinations: Yes: two-thirds of the foetuses
- Head examinations: No data
- Visceral examination: Yes: one-third of the foetuses
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- One female from the low dose group was killed in extremis and the cause of death could not be established with certainty.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gains were decreased by 14% and 28% during the gestation period 0-20 at 600 and 1200 mg/kg bw/day, respectively when compared to the control values. However, during the post dosing period, the body weight gains were increased in animals treated with mid and high dose levels such that by termination day 29 their body weights were comparable to that of the controls.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food intakes were also decreased by 11% during the dosing period at 1200 mg/kg bw/day dose levels.
Maternal developmental toxicity
- Number of abortions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Three females (1 from the control group, 1 from mid dose group and 1 from high dose group) aborted during the study period. These abortions were considered not to be treatment related.
- Pre- and post-implantation loss:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in number of pregnant:
- effects observed, treatment-related
- Description (incidence and severity):
- THe overall rate of pregnancies significantly decreased in mid and high dose treated rabbits (control = 100%, low dose = 100%, mid dose = 60% and high dose 67%).
- Other effects:
- no effects observed
- Description (incidence and severity):
- The number of corpora lutea showed no differences between the treated and control groups.
Effect levels (maternal animals)
- Dose descriptor:
- LOEL
- Effect level:
- 600 mg/kg bw/day
- Basis for effect level:
- body weight and weight gain
- changes in number of pregnant
- food consumption and compound intake
- mortality
Maternal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Due to the apparent effect on the maintenance of pregnancy in females receiving 600 mg/kg bw/day and above, the sponsor repeared part of the experiment. In this repeat test three groups were included in which pregnant rabbits were given oral doses of 0 (vehicle), 300 and 600 mg/kg from day 6 to 19 of gestation. This experiment had a few problems, such as older rabbits were used and were not in an active growth phase (even control rabbits lost their weights during the gestation period). Hence, no conclusion could be made from this study.
Applicant's summary and conclusion
- Conclusions:
- Maternal toxicity was seen at 600 and 1200 mg/kg bw/day dose levels. Additionally, mid and high dose levels adversely affected the pregnancy rates (reason unknown). However, there was no evidence of a teratogenic potential.
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