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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- 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 - 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.
- 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)
- Positive control results:
- DCNB (positive control) was a strong sensitizer in this study, confirming the susceptibility of this group of animals to dermal sensitization.
- 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..
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the results of a GLP compliant study, which was similar/equivalent to OECD Guideline 406 (Skin Sensitisation), 6 -HNA was determined to not have the potential to cause skin sensitization.
Migrated from Short description of key information:
In a GLP compliant study, the substance of record, 6-hydroxy-2-naphthoic acid (6-HNA) was determined to have no potential to cause dermal sensitization. The study was performed using appropriate controls, and the test system responded to the positive controls as expected.
Justification for selection of skin sensitisation endpoint:
Lack of dermal sensitization potential was established in a study similar/equivalent to OECD Guideline, and was performed under GLPs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of a GLP compliant OECD Guideline study, 6 -HNA was determined to not have sensitization potential via the dermal route of exposure. No data are available regarding respiratory sensitization. However, based on the fact that 6 -HNA is exclusively imported as a reacted monomer in a polymer backbone, the risk of respiratory exposure is low, and the risk of respiratory sensitization is considered to be negligible.
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