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Diss Factsheets
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EC number: 295-363-7 | CAS number: 92044-84-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles: pre-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test substance was applied to animals once a day for 10 days with a rest period between the fifth and sixth applications.
- 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:
- - Name of test material (as cited in study report): MRD-64-3
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: individually
- Diet (e.g. ad libitum): chow ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Route of Administration: dermal
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 ml/kg at doses of 0.5 or 2.5 ml/kg (400 or 2280 mg/kg-bw/day, respectively)
- Concentration (if solution): assumed 100%
- Constant volume or concentration used: yes - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 daily applications with a two-day rest between the 5th and 6th applications.
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5 or 2.5 ml/kg
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 4
- Control animals:
- other: isopropyl alcohol at 2.5 ml/kg
- Positive control:
- Isopropyl alcohol
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily for signs of irritation
BODY WEIGHT: Yes
- Time schedule for examinations: study termination
HAEMATOLOGY: Yes
- Time schedule for collection of blood: initially and prior to the final application
- Parameters checked in table: total erythrocyte count, total and differential leukocyte count, hematocrit.
NECROPSY
- Brain, thyroid, lungs, heart, liver, kidneys, adrenals, skin, bone marrow. - Sacrifice and pathology:
- HISTOPATHOLOGY: Yes, liver and kidney
- Other examinations:
- N/A
- Statistics:
- N/A
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- GENERAL APPEARANCE AND BEHAVIOR
Wheezing was noted in one animal at the 0.5 ml dose level. Animals at the lower dose level generally showed an overall body weight gain while those at the high level showed terminal weight losses.
DERMAL IRRITATION
The low level animals generally showed slight erythema and moderate atonia and desquamation following the first or fourth application and during the remainder of the study. At the high level, moderate erythema and moderate or marked atonia and desquamation were present in all animals. In addition, slight edema was present following the fifth application and slight fissures or cracks were observed in several animals following the last seven applications. The exposed skin also became hypersensitive to the touch.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- Systemic effects
- Effect level:
- 2.5 other: ml/kg
- Sex:
- male
- Basis for effect level:
- other: No adverse effects related to treatment.
- Dose descriptor:
- LOAEL
- Remarks:
- Local effects
- Effect level:
- 0.5 other: ml/kg
- Sex:
- male
- Basis for effect level:
- other: Skin irritation.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
0.5 ml/kg | 2.5 ml/kg | |||||||
24 hours after application No. | Erythema | Atonia | Desquamation | Erythema | Edema | Atonia | Desquamation | Fissures |
1 | + (4) | + (4) | ||||||
2 | (4) | ++(4) | ||||||
3 | + (4) | + (4) | + (4) | ++(4) | ++(4) | |||
4 | + (4) | ++(4) | ++(2)+(2) | ++(4) | ++(4) | + (4) | +(1) | |
5 | + (4) | ++(4) | ++(4) | ++(4) | + (4) | +++(3)++(1) | +++(2)++(2) | +(1) |
6 | + (4) | ++(4) | ++(4) | ++(3)+(1) | +++(3)++(1) | +++(3)++(1) | +(4) | |
7 | + (4) | ++(4) | ++(4) | ++(4) | +++(3)++(1) | +++(4) | +(2) | |
8 | ++(1)+(3) | ++(4) | ++(4) | ++(4) | +++(3)++(1) | +++(4) | +(2) | |
9 | ++(1)+(3) | ++(4) | ++(4) | ++(4) | +++(4) | +++(4) | +(2) | |
10 | ++(1)+(3) | ++(4) | ++(4) | ++(4) | +++(4) | +++(3)++(1) | +(2) | |
Key: + = slight; ++ = moderate; +++ = severe; number in paraenthesis is number of animals showing the sign. |
Applicant's summary and conclusion
- Conclusions:
- No NOAEL was identified; no adverse systemic effects were reported.
- Executive summary:
In this study, neodecanoic acid was applied repeatedly (once daily for 10 applications with a rest period on days 5 and 6) to the skin of rabbits at doses of 0.5 or 2.5 ml/kg. All animals survived the exposure. Wheezing was noted in one animal at the 0.5 ml dose level. Animals at the lower dose level generally showed an overall body weight gain while those at the high level showed terminal weight losses. The low level animals generally showed slight erythema and moderate atonia and desquamation following the first or fourth application and during the remainder of the study. At the high level, moderate erythema and moderate or marked atonia and desquamation were present in all animals. In addition, slight edema was present following the fifth application and slight fissures or cracks were observed in several animals following the last seven applications. The exposed skin also became hypersensitive to the touch. There were no indications of systemic toxicity are attributable to exposure.
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