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EC number: 279-013-0 | CAS number: 78948-87-5
- 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
- Study period:
- 2006
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, 22147 Hamburg, Germany
- Limit test:
- no
Test material
- Reference substance name:
- Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)
- EC Number:
- 279-013-0
- EC Name:
- Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)
- Cas Number:
- 78948-87-5
- Molecular formula:
- C16H8MgO10.2H
- IUPAC Name:
- Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)
- Details on test material:
- Test material magnesium-mono-peroxyphthalate (MMPP)
Lot/Batch numberBatch no. 251338
Expiration date of the lot/batch: October 05, 2006
Description White solid powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Own bred
- Age at study initiation: 4 to 5 months at day 0 of gestation
- Weight at study initiation: 2.3 to 3.0 kg at day 0 of gestation
- Fasting period before study: not reported
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 55+/-15
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua ad iniectabilia
- Details on mating procedure:
- Until observation of copulation. Day of copulation was considered as Day 0 of pregnancy
- Duration of treatment / exposure:
- Day 6 – 28 of pregnancy
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20 dams with litters in groups 0, 60 200 and 400
10 dams with litters in group 600 - Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Body weight Once daily from day 0 through 29; Data in report were given as mean values for days 0, 3, 6, 9, 12, 15, 18, 21, 24, 27 and 29 and as weight gains for three days intervals
Food consumption:Yes, once daily
Clinical signs: Yes – at least once daily - Ovaries and uterine content:
- Gravid uterine weights, ovarian corpora lutea counted and uterine contents determined (number of implantation sites, dead or live fetuses, placentae, number and size of resorptions)
- Fetal examinations:
- General: Number of fetuses per litter, litter size, no. of dead fetuses, foetal weight, sex ratio, inspection for external malformations and variations
Skeletal: Yes, skeletal malformations and variations/retardations
Soft tissue: Yes, visceral malformations and variations - Statistics:
- Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- From the remaining 21 dams in the 600 mg dose group, two aborted. In three of the remaining 19 dams haemorrhagic faeces were noted over one to three days.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 400 mg/kg bw., one of 23 pregnant dams died prematurely with signs of gastric and pulmonal changes. The dose of 600 mg/kg induced two pre-terminal deaths (from 24 dams) and one further pre-terminal sacrifice in moribund condition. Macroscopic organ findings were gastric, spleenic and /or hepatic lesions. Signs preceding deaths were reduced motility and /or soft haemorrhagic faeces.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 600 mg/kg bw., body weights were significantly reduced in phases (up to -8% from controls).
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 200 and 400 mg/kg bw., both absolute and relative food consumption were distinctly reduced especially during the first three treatment days (with up to 44 or 72% below the control values) and for the relative food consumption on gestation days 7 to 9. At 600 mg/kg, absolute and relative food consumption were distinctly reduced especially during the first week of treatment.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Uterus weights: At 600 mg/kg, gravid uteri weights were reduced due to the decreased number of fetuses.
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Description (incidence and severity):
- A total post-implantation loss was noted in 2 of 22 surviving dams at 400 mg/kg and in 9 of 19 surviving dams at 600 mg/kg.
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- At 400 mg/kg and 600 mg/kg, the number of early and total resorptions was increased and the number of fetuses was decreased.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- food consumption and compound intake
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Changes in postnatal survival:
- effects observed, treatment-related
- Description (incidence and severity):
- The foetal mortality during the incubator stay was increased, as 3 of 37 fetuses died within 6 to 24 hours after laparotomie.
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Variations: Skeletal examination revealed increased foetal incidences of fused sternebrae and/or total skeletal variations from 400 mg/kg bw. onwards. The incidences were, however, still within the historical background data of the laboratory.
Soft tissue examinations: No effects
Retardations: No effects
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: increased resorptions and decreased number of fetuses
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a study according to OECD 414 (2001) Himalayan rabbit was administered 3 dose levels by oral gavage during major organogenesis and foetal development. MMPP resulted in slight (200 mg/kg) to moderate (400 mg/kg) up to severe maternal toxicity at 600 mg/kg bw. Due to maternal toxicity, developmental effects were seen in fetuses from 400 mg/kg bw. onwards in form of increased resorption rates and concomitantly decreased number of fetuses. There was no indication that MMPP might be capable of inducing abnormalities or malformations in fetuses and thus MMPP is not teratogenic in rabbit fetuses.
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