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EC number: 429-220-9 | CAS number: 132584-17-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.34 (One-Generation Reproduction Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-220-9
- EC Name:
- -
- Cas Number:
- 132584-17-9
- Molecular formula:
- C17 H18 O4
- IUPAC Name:
- ethyl 2-hydroxy-2-(4-phenoxyphenyl)propanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: 87.8%
Batch: MAY94MB002/005
Test animals
- Species:
- rat
- Strain:
- other: CR1:WI(Han)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Frequency of treatment:
- Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week - Details on study schedule:
- Number of litters per dose/conc.: 1 at mg/kg or mg/l
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- Dose level started at 1000 mg/kg but was reduced to 500 mg/kg on day 3 of week 4
- No. of animals per sex per dose:
- Male: 20 animals at 1000 mg/kg or mg/l
Male: 20 animals at 500 mg/kg or mg/l
Female: 20 animals at 500 mg/kg or mg/l - Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
poorly tolerated by male rats in terms of reduced food
intake and body weight loss. Therefore, males were not dosed
on Day 2 of Week 4 and dose level was reduced from day 3 of
Week 4 to 500 mg/Kg/day.
There was some apparent distress during treatment indicated
by salivation, paddling, mouth-rubbing and a slight raising
of the tail immediately after dosing in treated males from
Week 2 until the end of the study and in treated females
from Week 1 until the end of the study. These findings were
considered to be caused by taste aversion rather than
systemic toxicity.
From Week 4 of treatment the test males were observed as
having increased water consumption compared to controls and
they were provided with one extra water bottle per cage for
the rest of the study.
Overall, treated males lost weight between Weeks 2 and 3,
prior to reduction in the dose level from 1000 to 500
mg/kg/day. After this change to the dose level, mean body
weight gain in the males was similar to controls. There was
a treatment-related decrease in body weight gain in treated
females compared to controls from Day 14 of gestation until
Day 4 of lactation.
Mean food intake for treated males was lower than controls
over the first three weeks of dosing, but recovered after
the dose level was reduced. There was a reduction in food
intake in treated females over the entire lactation period,
compared to controls.
At necropsy seventeen treated males and six treated females
had macroscopically abnormal findings of the kidney that
included green, pale, irregular surface and large. These
findings were considered likely to have been caused by
treatment but their toxicological significance is unclear.
There were no microscopic findings in treated animas due to
effects of the test article.
In summary, JG303 was well tolerated by males and females at
500 mg/kg/day, but this was considered to be the maximum
tolerated dose level.
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
Results: F1 generation
Details on results (F1)
Mean number of implantations sites and consequently mean
number of pups born was significantly lower in treated
females (9.2 and 8.4, respectively) compared to controls
(11.8 and 11.1, respectively). There was no significant
difference between groups in birth weights or survival of
pups born. During lactation mean body weight gain in pups
from the treatment group was significantly lower than
controls. These were considered to be effects of treatment.
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- JG303 was well tolerated by males and females at 500 mglkg/day, and in view of the post-treatment distress caused by apparent taste aversion, 500 mglkg/day can be considered to be the effective no observed toxic effect level. The slight reduction in implantation and reduction in body-weight gain of offspring in the treated group at the apparent highest tolerated dose level is not considered to warrant classification of substances as hazardous in relation to reproductive effects.
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