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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 240-759-7 | CAS number: 16712-64-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP status not stated; Well-documented, method employed consistent with OECD 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 6-hydroxy-2-naphthoic acid
- EC Number:
- 240-759-7
- EC Name:
- 6-hydroxy-2-naphthoic acid
- Cas Number:
- 16712-64-4
- Molecular formula:
- C11H8O3
- IUPAC Name:
- 6-hydroxynaphthalene-2-carboxylic acid
- Reference substance name:
- 6-HNA
- IUPAC Name:
- 6-HNA
- Details on test material:
- - Name of test material (as cited in study report): HNA
- Physical state: Solid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- A total of 45 animals (23 male; 22 female) were obtained for study.
TEST ANIMALS
- Source: Dutchland Breeding Farms; Denver, PA
- Age at study initiation: not stated
- Weight at study initiation: not stated
- Housing: Individually housed, type of housing not described.
- Diet (e.g. ad libitum): Base diet not described, fresh greens were used to supplement the diet.
- Water (e.g. ad libitum): not stated
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- not stated
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Test article was prepared as a suspension of 25% (w:v) 6-hydroxy-2-naphthoic acid in peanut oil. The preparation was blended to produce an homogenous suspension.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Test article was prepared as a suspension of 25% (w:v) 6-hydroxy-2-naphthoic acid in peanut oil. The preparation was blended to produce an homogenous suspension.
- No. of animals per dose:
- Group 1 - Peanut Oil (Vehicle Control): 15 total (8M & 7F)
Group 2 - DCNB (Positive Control): 15 total (8M & 7F)
Group 3 - Test Article: 15 total (8M & 7F) - Details on study design:
- Dosing Procedure:
- Sensitization Period: Test article application site was prepared (clipped free of hair) 24 hours prior to the initial dosing of each animal. All animals in all groups received 0.2 mL dosing solution applied to the back, on the right side of the spinal column below an "Elastopatch(R), with 3/4" x 1" Webril pad. The trunk of each animal was wrapped in an Elastoplast(R) bandage to occlude and secure the patches. After treatment, the animals were returned to their cages. Six hours after application, the bandages and patches were removed. Sensitization was performed three times a week for three weeks, for a total of 9 sensitizing exposures.
- Challenge Procedure: On the thirteenth day following the last Sensitization treatment, the treatment area of each animal was once again clipped free of hair and depilated with Neet(R). On the following day, all animals received the first challenge dose. However, in the challenge phase, two sites (one on either side of the spinal column) were treated. After 6 hours, both sites were evaluated for erythema and edema. Challenges were repeated at 24 and 48 hours. - Challenge controls:
- As an additional control, a group of 5 unsensitized animals were treated with the test material.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DCNB)
Results and discussion
- Positive control results:
- DCNB (positive control) was a strong sensitizer in this study, confirming the susceptibility of this group of animals to dermal sensitization.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 6
- Group:
- negative control
- Dose level:
- Vehicle Control
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- No edema observed in any animals; Very mild erythema observed in 2/10 animals. In one, erythema not bi-lateral, but persisted from 24 to 48 hours post-challenge. In other animal, erythema was bi-lateral, but only present at 24 hours post-challenge.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 6.0. Group: negative control. Dose level: Vehicle Control. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: No edema observed in any animals; Very mild erythema observed in 2/10 animals. In one, erythema not bi-lateral, but persisted from 24 to 48 hours post-challenge. In other animal, erythema was bi-lateral, but only present at 24 hours post-challenge..
- Reading:
- 1st reading
- Hours after challenge:
- 6
- Group:
- positive control
- Dose level:
- 1% DCNB in peanut oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema observed in all animals; Mild edema observed in 1/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 6.0. Group: positive control. Dose level: 1% DCNB in peanut oil. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Erythema observed in all animals; Mild edema observed in 1/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 6
- Group:
- test chemical
- Dose level:
- 25% 6-hydrox-2-naphthoic acid in peanut oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No observations of erythema or edema in any animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 6.0. Group: test group. Dose level: 25% 6-hydrox-2-naphthoic acid in peanut oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No observations of erythema or edema in any animals.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle Control
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- No edema observed in any animal; 3 animals had single mild erythema obs, one-sided; One animal had bi-lateral erythema at 48 hours post Challenge 2.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: Vehicle Control. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: No edema observed in any animal; 3 animals had single mild erythema obs, one-sided; One animal had bi-lateral erythema at 48 hours post Challenge 2..
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% DCNB in peanut oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema (slight to well-defined) observed in all animals; Very slight to slight edema observed in 3/10 animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 1% DCNB in peanut oil. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Erythema (slight to well-defined) observed in all animals; Very slight to slight edema observed in 3/10 animals. .
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% 6-hydroxy-2-naphthoic acid in peanut oil
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- One animal with a single, one-sided observation of very slight edema @ 24 hours post-challenge 2; one animal with single, one-sided observation of slight erythema at 24 hours post-challenge 2.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25% 6-hydroxy-2-naphthoic acid in peanut oil. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: One animal with a single, one-sided observation of very slight edema @ 24 hours post-challenge 2; one animal with single, one-sided observation of slight erythema at 24 hours post-challenge 2..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of this study, no potential to produce dermal sensitization in the guinea pig was demonstrated by 6-HNA.
- Executive summary:
No signs of systemic toxicity were noted in any animals during this study. Sporadic incidences of urinary and fecal staining of the abdomen, soft stool, piloerection, and animal thinness were noted during this study. There was no severe dermal response noted in any of the animals treated with 6 -HNA. The reactions following each challenge were similar for both control animals and those treated with 6 -HNA. DCNB (positive control) was a strong sensitizer in this study, confirming the susceptibility of this group of animals to dermal sensitization.
Under the conditions of this study, no potential to produce dermal sensitization in the guinea pig was demonstrated by 6 -HNA.
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.