Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-662-8 | CAS number: 1338-24-5
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: although no indication that it is a GLP study, sufficient detail is provided to make a conclusion about its validity.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- other: robust study summary
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- This study is a combined study where Accute Dermal Toxicity is considered together with skin irritation.
- Principles of method if other than guideline:
- This study is a combined study where Accute Dermal Toxicity is considered together with skin irritation.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Naphthenic acids
- EC Number:
- 215-662-8
- EC Name:
- Naphthenic acids
- Cas Number:
- 1338-24-5
- Molecular formula:
- For the acidic (naphthenic) fraction: CnH2n+zO2, where n = carbon number and z = homologous group series number: z = 0 when no ring structures are present, z = -2 when 1 ring is present, z = -4 when 2 rings are present etc. For the non-acidic fraction: not applicable
- IUPAC Name:
- 11-(decahydronaphthalen-2-yl)undecanoic acid; 11-cyclopentylundecanoic acid; 15-cyclohexylpentadecanoic acid; 3-(tetradecahydroanthracen-2-yl)propanoic acid; 4-(tetradecahydroanthracen-2-yl)butanoic acid; 7-(tetradecahydroanthracen-2-yl)heptanoic acid; 9-(octahydropentalen-2-yl)nonanoic acid; dodecahydro-1H-phenalene-1-carboxylic acid
- Test material form:
- liquid
- Details on test material:
- Physical state: Viscous liquid
Appearance: Pale yellow to dark amber
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
Dermal irritation was recorded at 24h, 3, 7, 10 and 14 days. - Number of animals:
- 2 per sex
- Details on study design:
- 3.16 g/kg naphthenic acid was applied dermally to the clipped abraded abdomens of 2 female and 2 male New Zealand White Rabbits. The area was covered with gauze and secured by a thick plastic binder, which was removed atfter 24 hours, and the skin washed with water or corn oil.
Following the skin wash, animals were observed for mortality and toxic effects at 2 hr and 4 hr, and once daily thereafter. Body weights were recorded pretest and at termination. Dermal irritation was recorded at 24 hr, 3, 7, 10 and 14 days.
The rabbits were observed 1, 2, 4 and 6 hours after dosing and once daily for 14 days. Mortality, toxicity and pharmacological effects were recorded. Body weights were recorded pretest and in the survivors at 14 days. At 14 days the survivors were sacrificed. Animals were examined for gross pathology.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.69
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Other effects:
- The initial response of the skin to the test material was slight. with Iittle difference in response between intact or abraded sites.
Any other information on results incl. tables
Table 1. Erythema scores
Animal |
1 day |
3 day |
7 day |
10 day |
14 day |
Number |
|||||
1M |
2 |
2 |
4 |
4 |
1 |
2M |
1 |
2 |
4 |
4 |
1 |
3F |
2 |
4 |
4 |
4 |
0 |
4F |
2 |
3 |
4 |
4 |
0 |
Note: All animals showed signs of scar formation after 14 days. |
Table 2. Edema scores
Animal |
1 day |
3 dav |
7day |
10 day |
14 day |
Number |
|||||
1M |
3 |
2 |
2 |
2 |
1 |
2M |
2 |
3 |
2 |
2 |
0 |
3F |
3 |
3 |
2 |
2 |
0 |
4F |
3 |
3 |
2 |
2 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The material was judged to be moderately to severely irritating to the occluded skin.
- Executive summary:
New Zealand white rabbits were dermally treated with 3.16 g/kg Naphthenic acids under occlusive dressing for 24 hours, afeter which the skin was washed with water or corn oil. The rabbits were observed 1, 2, 4 and 6 hours after dosing and once daily for 14 days. No deaths occurred at the 3.16 mg/kg dose level. Redness and irritation scores were recorded at 24 hr, 3, 7, 10 and 14 days post-washing. Mean values (24, 48 & 72 hours) for erythema and edema at the intact sites were 1.69 and 1.3 respectively. The initial response of the skin to the test material was slight, with little difference in response between intact or abraded sites. Erythema and edema were partly reversible after 14 days; all animals showed signs of scar formation after 14 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
