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EC number: 257-446-6 | CAS number: 51818-55-4
- 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:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- 3 generations used, dietary administration
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Neodecanoic acid
- EC Number:
- 248-093-9
- EC Name:
- Neodecanoic acid
- Cas Number:
- 26896-20-8
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 2-ethyl-2,5-dimethylhexanoic acid
- Details on test material:
- TS-Freetext:
CAS No. 26896-20-8; Neodecanoic acid (2,2-dimethyloctanoic acid)
- Name of test material (as cited in study report): MRD-67-21
- Physical state: clear liquid with a faint odor
- Analytical purity: assumed 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: (P) young
- Weight at study initiation: (P) Males: 108-164 g; Females: 101-144 g
- Diet (e.g. ad libitum): prepared, ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Fresh diets were prepared every 2 weeks or weekly as needed.
- Mixing appropriate amounts with (Type of food): Purina Laboratory Chow
- Storage temperature of food: Room temperature - Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation: week
- After successful mating each pregnant female was caged (how): individually - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Premating exposure period (males): P1: 9 weeks
Premating exposure period (females): P1: 9 weeks
Duration of test: 3 generations - Frequency of treatment:
- Continuous
- Details on study schedule:
- P1 GENERATION
Prior to initiation of the first and second breeding phases, the parental generation animals were maintained in individual cages and fed the appropriate diets until they reached maturity, 9 weeks. At the end of the ninth week, two females and one male within each group were mated. Males were rotated for 3 weeks.
F1A GENERATION
Twenty-four hours after birth, the F1A litters were arbitrarily reduced to a maximum of eight pups for nursing. After 21 days, representative pups from each litter were sacrificed and gross necropsies were performed. All other weanlings were discarded.
F1B GENERATION
One week after weaning the last F1A litter, the P1 parents were re-mated are previously described to produced the F1B generation. After a 21-day nursing period, 20 female and 10 male weanlings were designated as the P2 generation. One third of the remaining weanlings were gross necropsied, the remaining were discarded.
P2 GENERATION
The P2 animals were individually hosed until they reached 100 days of age. Mating occurred as described previously.
F2A GENERATION
As described previously – F1A
F2B GENERATION
As described previously – F1B
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Remarks:
- Control, in diet
- Dose / conc.:
- 100 ppm (nominal)
- Remarks:
- Low dose, in diet. Equals approximately 5 mg/kg bw/day, respectively.
- Dose / conc.:
- 500 ppm (nominal)
- Remarks:
- Mid dose, in diet, equals approximately 25 mg/kg bw/day, respectively.
- Dose / conc.:
- 1 500 ppm (nominal)
- Remarks:
- High dose, in diet, equals approximately 75 mg/kg bw/day, respectively.
- No. of animals per sex per dose:
- 20 Females, 10 Males
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- Observations were made at 5 and 9 weeks
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- Immediately after birth
- Postmortem examinations (parental animals):
- All parent animals
- Postmortem examinations (offspring):
- All offspring
- Statistics:
- N/A
- Reproductive indices:
- Fertility, gestation, live birth, lactation.
- Offspring viability indices:
- Fertility, gestation, live birth, lactation.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One control P1 female was found dead following the second mating period (F1B). The right adrenal was enlarged and dark red in color, and the lungs were dark red in color. The observation was not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
No effects noted
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
No effects noted
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
No effects noted
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
No effects noted
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
No effects noted
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No effects noted
ORGAN WEIGHTS (PARENTAL ANIMALS)
No effects noted
GROSS PATHOLOGY (PARENTAL ANIMALS)
No effects noted
HISTOPATHOLOGY (PARENTAL ANIMALS)
No effects noted
OTHER FINDINGS (PARENTAL ANIMALS)
No effects noted
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Two intermediate dose P1 males were found dead following the first (F2A) mating period. The gastrointestinal tract of both animals was filled with gas, the lungs of one were dark gray in color, and the lungs of the other were distended and dark red with grayish areas. One control P1 female was found dead following weaning of the F2B litter. Necropsy findings included advanced autolysis; pituitary and thymus dark red consolidated and abscessed areas on lungs; liver and kidneys dark red with dark black areas; poor differentiation between cortex and medulla of kidneys; pyloric portion of stomach red; and intestinal tract red and contained blackish red, semithick material. The observations were not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P1)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
Target system / organ toxicity (P1)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Mutilation of pups found dead at birth was noted in one control and two high level F1 litters. The observation was not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
F2A and F2B – The various indices, litter size, pup body weights, appearance, and behavior of the newborn and of the pups during lactation were comparable among the control and test groups for both cycles. At birth, two pups from one high level F2A litter were found cold to the touch. Minor incidental findings were also noted.
Effect levels (F1)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1a
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1b
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Mutilation of pups found dead at birth or during the nursing period was noted in one control F2 litter and in one low level litter in the F2A and F2B cycles each. The observation was not considered treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
Effect levels (F2)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2a
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
- Dose descriptor:
- NOAEL
- Generation:
- F2b
- Effect level:
- 1 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity observed
Target system / organ toxicity (F2)
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In conclusion, no adverse effects on reproduction or development were noted.
- Executive summary:
In a three-generation reproduction study (equivalent to OECD 416), the effects of long-term ingestion of neodecanoic acid on reproduction was evaluated in albino rats. Neodecanoic acid was administered in the diet at levels of 100, 500, and 1500 ppm fed to the rats through two parental and to two-litter filial generations. Following nine weeks of dietary administration to the F2B weanlings designated as the third parental generation, the study was terminated. There was no evidence at any test level of an adverse effect on the survival, appearance, behavior, body weight gain, and food consumption of the parental generations; on the reproductive performance of the parents reflected by the various indices; or on the growth, appearance, and behavior of the offspring. Gross and macroscopic pathological findings revealed no evidence of a compound-related effect at any of the dietary levels. Based on these results, the NOAEL (F0, F1 and F2) is considered to be greater than 1500 ppm.
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