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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
Conclusions for dermal and ocular irritation based on OECD Guideline studies, performed under GLP for the read-across substance 3-hydroxy-2-naphthoic acid (3-HNA).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983-09-13 - 1983-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study, performed to OECD Guideline, performed under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG breeding colony
- Weight at study initiation: 2,2 - 2,6 kg
- Housing: single cages
- Diet (e.g. ad libitum): Rabbit diet Altromin 2123, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/-10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: PEG 400
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/patch suspended in 0.32 ml PEG 400
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- Animals were exposed to test article for 4 hours.
- Observation period:
- Primary observation at 30-60 minutes after removal of patch, with subsequent observations at 24, 48 and 72 hours post patch-removal.
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm patch
- % coverage: Not given
- Type of wrap if used: Cellulose acetate patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scored according to Draize. A test substance is considered to be a skin irritant if it causes an inflammation of the skin, the exposure time up to 4 hours to 24 hours or longer lasting, and corresponds to the following values: mean erythema score or edema score above 2. - Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 48 h
- Irritant / corrosive response data:
- erythema and edema recorded.
- Other effects:
- No other effects were reported
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- not irritating under the test conditions.
The mean Draize scores for erythema and edema derived from 24, 48 and 72 hour post treatment observation time points were 0.3 in each of three rabbits. All erythema and edema findings were completely reversible within 48 hours post patch removal. Based on these findings the test substance was considered "not irritant". - Executive summary:
- According to the classification criteria of the REGULATION (EC) No 1272/2008EC, and taking into account all relevant toxicological findings, the substance BONS TTR can be described as a not irritating.
Reference
Average Values for Erythema and Eschar
Animal 1 | 0.3 |
Animal 2 | 0.3 |
Animal 3 | 0.3 |
Average for all Animals | 0.3 |
Average values for Edema
Animal 1 | 0.3 |
Animal 2 | 0.3 |
Animal 3 | 0.3 |
Average for all Animals | 0.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989-09-13 - 1983-10-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study, performed to OECD Guideline, performed under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG breeding colony,
- Weight at study initiation: 2.7 - 3.9 kg
- Housing: singla cage
- Diet (e.g. ad libitum): rabbit diet Altromin 2123, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/-10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- other: PEG 400
- Controls:
- other: untrreated eye regarded as control
- Amount / concentration applied:
- 100 mg test substance mixed with 0.1 mL PEG 400
- Duration of treatment / exposure:
- 24 hours. Thereafter the eyes were rinsed with physiological saline (37°C)
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were evaluated at: 1, 24, 48 and 72 hours and on days 7 and 14 after application. Grades attained at 24, 48 and 72 hours after application were included in the mean gradings of ocular lesions.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24,48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) were observed at any time
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- All findings covered by the scoring system were fully reversible within the observation period of 14 days.
Additional response date:
Discharge: from 1 to 72 h post application, fully reversible within 7 days
Nicitating membrane: partial gray discoloration, fully reversible within 14 days
Cornea surface: uneven, not reversible within the observation period of 14 days
Corneal vascularization: starting at day 7, advanced at day 14, not reversible within the observation period of 14 days - Other effects:
- no other effects reported
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- In view of the corneal lesions still evident at the end of the observation period (14 days) and considered to be irreversible the test substance was considered to pose a risk of serious damage to eyes.
- Executive summary:
- According to the classification criteria of the EC Directive,with particular attention to the time during the trial where corneal damage is not reversible, the substance BONS TTR is described as irritating to the eye. There is the"danger of serious damage to eyes".
3-Hydroxy-2-naphthoic acid was tested for eye irritation according to OECD Guideline 405 and in compliance with GLP. Each of three New Zealand White rabbits was treated by administration of a single dose of 100 mg test substance mixed with polyethylene glycol 400 (0.1 ml) to the conjunctival sac of one eye. Eyes were evaluated for ocular lesions at 1, 24, 48 and 72 hours and on days 7 and 14 after application. At 1 hour after application, swelling and conjunctival injection as well as secretion (clear, tinted by the test substance) were observed in all animals. At 24, 48 and 72 hours, conjunctivitis and diffuse corneal opacities were found. One animal showed iritis at 24 and another at 48 hours. At 7 and 14 days after the application,unevencorneal surface and/or corneal vascularization were seen in all animals. In view of the corneal lesions still evident by 14 days post application and considered to be irreversible the test substance was considered to pose a risk of serious damage to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation classification based on criteria established in REGULATION (EC) No 1272/2008. For the eye irritation endpoint, the actual irritation values would only place the substance in Category 2 ("irritating to eyes"). However, other effects which were not reversible within 21 days (Cornea surface: uneven, not reversible within the observation period of 14 days; Corneal vascularization: starting at day 7, advanced at day 14, not reversible within the observation period of 14 days) placed the substance in Category 1 ( "irreversible effects on the eye").
Justification for selection of skin irritation / corrosion endpoint:
Based on the criteria established in REGULATION (EC) No 1272/2008, the read-across substance 3-hydroxy-2-naphthoic acid would be considered not irritating.
Justification for selection of eye irritation endpoint:
Classic irritation, as defined by OECD
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the results of studies from the read-across substance, the substance of record, 6 -hydroxy-naphthoic acid (6 -HNA) would not be classified as a skin irritant, but would be classifed as a Category 1 eye irritant. These designations are based on criteria set forth in
REGULATION (EC) No 1272/2008.
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