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EC number: 923-835-0 | CAS number: -
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 27 November 2007 - 25 August 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions. The subsatnce in the study (Acetalization products between glucose and C16/18 (even numered) alcohol) is a member of the category The following information is at present available: - A pre-natal developmental study (OECD 414) with acetalization products between glucose and C16/18 (even numbered)-alcohol - A combined repeated dose-reproduction study (OECD 422) with acetalization products between glucose and C14 alcohol - A combined repeated dose-reproduction study (OECD 422) with acetalization products between glucose and C20/22 (even numbered) -alcohol In all studies a NOAEL of 1000 mg/kg bw was derived for reproduction and developmental effects. These data are considered sufficient to support the category approach, as they cover the different carbon chain lengths that are included in the category. For Annex IX a two generation reproduction toxicity study is requested. In view of the consistency across the category and based on the available data from the above mentioned studies on both reproductive performance and developmental effects, the toxicokinetic behaviour and the low exposure (see CSR), the two generation reproduction study is waived. Any effects on the male reproductive organs will be investigated in the 90-day study that is proposed with acetalization products between glucose and C16/18 (even numbered) -alcohol. Therefore the endpoints on fertility and reproduction are covered in a weight of evidence approach.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
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:
- Except for absence of chemical analysis of the dosage forms
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): LCE07051 = Acetalization product between glucose and C16/18(even numbered)-alcohol
- Substance type: UVCB
- Physical state: white powder
- Purity: not indicated
- Impurities (identity and concentrations): not indicated
- Percentage of components: not indicated
- Purity test date: not indicated
- Lot/batch No.: T70615
- Expiration date of the lot/batch: 7 February 2009
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature, protected from sunlight
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder
- Age at first treatment: 10-11 weeks
- Weight at first treatment (mean): 280 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Relative humidity: 50 ± 20%
- Light/dark cycle: 12h/12h
- Ventilation: 12 cycles/hour of filtered, non-recycled air.
IN-LIFE DATES: beginning: 3 December 2007 / end: 28 December 2007
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
test item was ground, heated to 80°C, mixed with vehicle heated to 80°C, forming a solution.
The test item dosage forms were prepared daily
VEHICLE
- Justification for use and choice of vehicle (if other than water): lipophilicity of the substance.
- Concentration in vehicle: 10, 30 and 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg/day
- Lot/batch no. (if required): 057K6093
- Purity: not indicated - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Absence of a practical method of analysis
- Details on mating procedure:
- - Impregnation procedure: purchased time pregnant
- Proof of pregnancy: vaginal plug - Duration of treatment / exposure:
- day 6 to day 20 post-coitum
- Frequency of treatment:
- once daily
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day (f)
Basis:
other: nominal per gavage
- No. of animals per sex per dose:
- 24 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: no effects on dams and development at up to 1000 mg/kg/day in a range-finding study, see 7.8.2
- Rationale for animal assignment: computerized stratification procedure (average body weight of each group is similar)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule: regularly at 3- to 4-day intervals
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined daily: Yes
WATER CONSUMPTION: No
POST-MORTEM MACROSCOPIC EXAMINATION: Yes
- Sacrifice on gestation day# 21
- Examined: principal thoracic and abdominal organs - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: number of uterine scars, evaluation of placenta - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter
- Other : number dead and live, body weight, sex - Indices:
- % Pre-implantation loss = 100 * (Number of corpora lutea - Number of implantation sites) / Number of corpora lutea
% Post-implantation loss = 100 * (Number of implantation sites - Number of live fetuses) / Number of implantation sites - Historical control data:
- Not provided; not required for interpretation of the data obtained
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation was observed in 0, 5, 9 and 20 females treated at 0, 100, 300 and 1000 mg/kg/day, respectively, during the second half of the treatment period and lasting from between 1 and 11 days.
One female from each group treated with LCE07051 showed soiled urogenital area on day 20 and/or 21 post-coitum.
These signs were considered to be related to treatment with the test item but are not adverse. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One female (Q23307) treated at 100 mg/kg/day was prematurely sacrificed on day 7 post-coitum because of clinical signs of loud breathing, dyspnea, chromorhinorrhea and salivation. At necropsy, perforations were found in the trachea and esophagus, there were oily contents in the thoracic cavity and a pouch of yellowish oily contents in the subcutaneous tissue (right axillary area). These necropsy findings and clinical signs were the result of a gavage error.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No abnormalities were observed in the females treated at 1000 mg/kg/day.
One female (Q23329) treated at 300 mg/kg/day had two fused placentae and one associated implantation site. This was considered to be spontaneous in origin.
One female (Q23314) treated at 100 mg/kg/day had a markedly reduced in size left kidney, atresia of the left uterine horn which was also malpositioned and contained serous contents. The right kidney was enlarged with a markedly dilated pelvis. These findings are considered to be congenital abnormalities. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The mean pre-implantation losses were slightly higher for the groups treated at 100 or 300 mg/kg/day when compared with the controls, although the mean pre-implantation loss of the group treated at 1000 mg/kg/day was similar to the control value. As a result the mean number of fetuses per female was minimally lower in the groups treated at 100 or 300 mg/kg/day but, again, was unaffected at 1000 mg/kg/day. Give the lack of dose-relationship, it was considered that these differences did not represent an effect of treatment with the test item.
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- he number of early resorptions was increased in all groups treated with LCE07051 when compared with the controls but the mean post-implantation losses were not significantly increased and were within CIT background data. In addition, for two groups (those treated at 100 or 1000 mg/kg/day) one half to one third of the early resorptions for each group occurred in one litter and it was therefore considered that these differences were not toxicologically relevant.
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were 4, 2, 2 and 1 non-pregnant females in each of the groups treated at 0, 100, 300 or 1000 mg/kg/day.
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Not required (no effects)
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- mortality
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- changes in number of pregnant
- changes in pregnancy duration
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
- other: developmental toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One fetus from the group treated at 1000 mg/kg/day had omphalocele (congenital herniation of viscera into the base of the umbilical cord). Given the fact that only one fetus in the high-dose group had an external abnormality it was considered to be unrelated to treatment with the test item.
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Not required (no effects)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in postnatal survival
- external malformations
- skeletal malformations
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Not required (no effects)
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day for maternal and developmental toxicity.
- Executive summary:
The test item, LCE07051, was administered daily, from day 6 to day 20 post-coitum, by the oral route (gavage), to mated female Sprague-Dawley rats at dose-levels of 100, 300 or 1000 mg/kg/day.
There were no test item-related mortalities nor any effects on maternal body weight gain or food consumption. Clinical signs were limited to salivation and several animals with soiled urogenital areas and were considered as non-adverse.
There were no treatment-related effects on pregnancy parameters (numbers of corpora lutea, implantation and live fetuses) nor on fetal body weight or sex.
There were no treatment-related fetal malformations. Several fetal variations were observed at soft tissue examination (absent innominate artery) and skeletal examination (ossification point on the 14th thoracic vertebra) but the incidences were low with no clear dose-relationship and there were no cartilage abnormalities. Variations at fetal examination are considered not to represent an adverse effect of development.
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