Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 205-550-7 | CAS number: 142-62-1
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Relative irritancy of free fatty acids of different chain length
- Author:
- Stillman, M.A. et al.
- Year:
- 1 975
- Bibliographic source:
- Contact Dermatitis 1:65 - 69
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Hexanoic acid and further fatty acids in 0.5 M and 1 M concentrations were applied daily under occlusive patch tests to human skin until detectable erythema appeared or until the experiment terminated after 10 consecutive days of applications. In addition intradermal injections of hexanoic acid in 0.01 M and 0.1 M concentrations were performed; each site was evaluated at 24 h and 48 h for erythema and induration.
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexanoic acid
- EC Number:
- 205-550-7
- EC Name:
- Hexanoic acid
- Cas Number:
- 142-62-1
- Molecular formula:
- C6H12O2
- IUPAC Name:
- hexanoic acid
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 35 in total: 20 volunteers for patch test (10 volunteers for 0.5 M fatty acids and 10 volunteers for 1.0 M fatty acids) and 15 volunteers for intradermal injections (5 volunteers for 0.01 M fatty acids and 10 volunteers for 0.01 M and 0.1 M of each fatty acid).
- Demographic information: white men, not further specified - Route of exposure:
- other: dermal (occlusive) and intradermal
- Reason of exposure:
- intentional
- Exposure assessment:
- not specified
- Details on exposure:
- The irritant potential of the test substance in human volunteers was evaluated after (A) dermal and (B) intradermal exposure.
A) For the dermal route, A1-test ® patches (Imeco, Astra Agency, Stockholm, Sweden) were saturated with 0.04 mL test solution (0.5 M and 1 M hexanoic acid in propanol) and applied on the interscapular area of the volunteers. The patch was held in place via occlusive coverage with a Blenderm® tape (Minnesota Mining and Manufacturing Company, St. Paul, MN, USA). After 24 h, the patches were removed and the skin reactions were evaluated 30 min later. If no erythema were visible, the volunteers were re-exposed for a maximum of 10 consecutive days. If erythema were present over the entire patch area, no further application occurred on the respective volunteer and the number of days needed to induce the erythema was recorded. Propanol saturated patches served as vehicle control and were applied to each volunteer.
B) For the intradermal route, 0.1 mL of the test solution (0.01 M and 0.1 M hexanoic acid in olive oil) were injected into the back of the volunteers. After 24 h and 48 h, each site was evaluated for erythema and induration. As vehicle control, olive oil was injected in all volunteers. - Examinations:
- A) Dermal application:
After 24 h exposure, the patches were removed and the skin reactions (erythema) were evaluated 30 min later.
B) Intradermal exposure:
24 h and 48 h after intradermal exposure, each site was evaluated for erythema and induration.
Results and discussion
- Clinical signs:
- A) Dermal application
0.5 M hexanoic acid induced erythema in 1 out of 10 volunteers after re-exposure for 7 consecutive days.
1 M hexanoic acid resulted in the formation of erythema in 7 out of 10 volunteers after a distinct number of treatments at consecutive days: 1 volunteer reacted after re-exposure for 2 days; 1 volunteer after 3 and and another volunteer after 7 days; 4 volunteers showed erythema after re-exposure for 8 days. The vehicle propanol did not induce erythema formation.
B) Intradermal injection
All volunteers showed slight indurations of 5 mm and mild erythema after injection of hexanoic acid (0.01 M and 0.1 M) and the vehicle control (olive oil). No difference between the test and control sites was visible.
Any other information on results incl. tables
Table 1: Cumulative number of subjects responding to 0.5 M and 1 M hexanoic acid (total of 10 subjects each)
Day |
0.5 M (5.8% w/v) |
1.0 M (11.6% w/v) |
1 |
0 |
0 |
2 |
0 |
1 |
3 |
0 |
2 |
4 |
0 |
2 |
5 |
0 |
2 |
6 |
0 |
2 |
7 |
1 |
3 |
8 |
1 |
7 |
9 |
1 |
7 |
10 |
1 |
7 |
Applicant's summary and conclusion
- Conclusions:
- Daily dermal application of 1 M hexanoic acid (11.6% (w/v)) resulted in erythematous responses in 7 out of 10 subjects till the termination of the study on day 10. One out of 10 volunteers showed erythema after daily dermal application of 0.5 M hexanoic acid (5.8% (w/v)). No differences between control and test sites have been noted after intradermal injections of 0.01 M or 0.1 M hexanoic acid.
Based on these results, hexanoic acid is considered to produce skin irritation in humans after chronic exposure in a concentration dependent manner.
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.