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EC number: 255-490-0 | CAS number: 41672-81-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline
- EC Number:
- 255-490-0
- EC Name:
- trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline
- Cas Number:
- 41672-81-5
- Molecular formula:
- C37H69NO5
- IUPAC Name:
- 1-palmitoyl-4-(palmitoyloxy)-L-proline
- Details on test material:
- See section 7.8.1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- see section 7.8.1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- see section 7.8.1
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- about 1 month for male and 54 days for females. See section 7.8.1
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw/d
Basis:
other: nominal concentration
- Remarks:
- Doses / Concentrations:
300 mg/kg bw/d
Basis:
other: nominal concentration
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/d
Basis:
other: nominal concentration
- No. of animals per sex per dose:
- Main groups : 10 males+10 females per group
Recovery groups : 5 males + 5 females per group
Total = 100 (50 males + 50 females) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- see section 7.8.1
Examinations
- Observations and examinations performed and frequency:
- see section 7.8.1
- Sacrifice and pathology:
- see section 7.8.1
- Statistics:
- see section 7.8.1
Results and discussion
Results of examinations
- Details on results:
- see section 7.8.1
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no significant effect noted
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- To summarize, oral administration of test item “ trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline” to Wistar rats at the dose levels 100, 300 and 1000 mg/kg Bwt/day had no effects on general health, body weights, food intake, pre-coital time, gestation length, mating and fertility parameters. Functional observations did not reveal any test item related changes at all the tested doses in both sexes. The live birth and survival index was not altered by the treatment at the entire tested dose. The test item administration did not reveal any treatment related changes in the hematology, coagulation and clinical chemistry parameters of both males and females. There were no test item related changes in the terminal body weights, organ weights and organs weight ratios in both males and females. Gross examination of pups on lactation day 4 did not reveal any gross changes.
There were no test item related gross and microscopic changes in both males and females
No Observed Adverse Effect Level (NOAEL):
As there were no adverse effects observed in any parameters up to the highest dose tested, the No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg/kg Bwt/day. - Executive summary:
Under experimental conditions described in the Material and Method section, the following results were obtained:
No clinical signs or mortality was observed during the course of the study.
No treatment-related neurological abnormalities /dysfunctions were observed at all the doses tested.
The body weights and food consumption were unaffected by the treatment at all the doses tested.
The body weights and food consumption were unaffected during gestation and lactation periods at all the doses tested.
There were no treatment-related changes in the hematology, coagulation and clinical chemistry parameters.
Treatment had no effect on pre-coital time or gestation length, mating and fertility parameters in both sexes.
There were no treatment-related effects on the uterine/implantation data, mean litter size and mean viable litter size.
There were no external abnormalities in live or dead pups in any of the groups.The Day 4 survival index was not altered by the treatment at all the doses tested.
The test item administration did not reveal any treatment related changes in the hematology, coagulation and clinical chemistry parameters of both males and females.
There were no test item related changes in the terminal body weights, organ weights and organs weight ratios in both males and females. Gross examination of pups on lactation day 4 did not reveal any gross changes.
There were no test item related gross and microscopic changes in both males and females.
No Observed Adverse Effect Level (NOAEL): As there were no adverse effects observed in any parameters up to the highest dose tested, the No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg/kg Bwt/day.
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