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EC number: 700-603-5 | CAS number: 908145-87-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 April 2011 to 14 April 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Deviation to good laboratory practices - the study director was not supplied with sufficient test article characterization information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate
- EC Number:
- 700-603-5
- Cas Number:
- 908145-87-9
- Molecular formula:
- C20 H27 N O6
- IUPAC Name:
- 1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate
- Details on test material:
- Pure active sample of Compound 2945989 was used to perform the testing.
Lot Number: 1050L027
Potency: Assume 100%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The animals were housed in individual cages. Absorbent paper bedding was placed beneath the cages and changed at least three times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: corn oil
- Controls:
- no
- Amount / concentration applied:
- The test article was individually weighed, 0.5 g/site and moistened with 1.0 ml of corn oil to form a pasty consistency. The test article was applied under a 2 x 3 cm gauze patch.
- Duration of treatment / exposure:
- The test article was kept in contact with the skin for 4 hours at which time the wrappings and patches were removed.
Residual test article was removed from the test site by gently washing with corn oil at the end of the exposure period, prior to scoring for dermal reactions - Observation period:
- The test sites were observed for dermal irritation at 1, 24, 48 and 72 hours following patch removal.
- Number of animals:
- Three healthy New Zealand White rabbits (2 males - 1 female)
- Details on study design:
- The test sites were scored for dermal irritation at 1, 24, 48 and 72 hours following patch removal. Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Erythema and edema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.
Body weights of all animals were recorded pretest and at study termination. All animals were humanely sacrificed using CO2 following study termination.
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Dermal Observations:
Very slight erythema was observed for one animal at 1 hour following 4 hour exposure. There was no other erythema or edema noted at any observation period. - Other effects:
- Systemic Observations:
There was no abnormal physical signs noted during the observation period.
All body weight changes were normal.
Any other information on results incl. tables
|
|
Rabbit 1 |
Rabbit 2 |
Rabbit 3 |
|
|
|
|
|
1 Hour |
Erythema |
0 |
0 |
1 |
|
Edema |
0 |
0 |
0 |
|
Systemic Sign |
A |
A |
A |
|
|
|
|
|
24 Hour |
Erythema |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
|
Systemic Sign |
A |
A |
A |
|
|
|
|
|
48 Hour |
Erythema |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
|
Systemic Sign |
A |
A |
A |
|
|
|
|
|
72 Hour |
Erythema |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
|
Systemic Sign |
A |
A |
A |
|
|
|
|
|
A = normal
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Compound 2945989, Lot/Batch# 1050 L 027 is not a dermal irritant.
- Executive summary:
In April 2011 a dermal irritation/corrosion study was conducted as per OECD Guideline 404. Three rabbits were dosed dermally with Intermediate 2945989. 0.5g of the test article was applied dermally to one intact site per rabbit and wrapped with a semi-occlusive dressing. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed.
Erythema and edema were scored at 1,24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Body weights were recorded pretest and at termination.
Summary:
Very slight erythema was observed for one animal at 1 hour following the 4 hour exposure. There was no other erythema or edema noted at any observation period. There were no abnormal physical signs noted during the observation period. All body weight changes were normal.
Conclusion:
Compound 2945989, Lot/Batch# 1050 L027 is not a dermal irritant.
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