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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 601-471-0 | CAS number: 117309-52-1
- 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
Endpoint summary
Administrative data
Description of key information
In the first study the skin irritancy potential of 2-(Naphthalene-2'-sulfonylamino)-benzoic acid was assessed on rabbit (OECD guideline number 204 of 1981). 2-(Naphthalene-2'-sulfonylamino)-benzoic acid
did not produce positive criteria in any rabbit according to the EC labelling regulations and was classified as NON-IRRITANT to rabbit skin.
In the second study, the eye irritancy potential of the 2 -(Naphtalene-2'-sulphonylamino)-benzoic acid was assessed on one rabbit (OECD Guideline No. 405 of 1987). A single application of the test material to the non-irrigated eye of one rabbit produced grade 4 corneal opacity, iridial inflammation and moderate conjunctival irritation. The test has been stopped and the animal was killed after 48h due to the persistance of grade 4 opacy. The evidence shows, that the test material could be classified according to EC labeling regulations into the Category 1 - producing serious eye damage but as the test was only carried out with one animal, it is insufficient for classification.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 11 February 1992 and 14 February 1992.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For the purpose of this study the test material was moistened with distilled water immediately before application.
- Final dilution of a dissolved solid, stock liquid or gel: 0.5g of the test material was moistened with 0.5 ml of distilled water - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.26 - 2.34 kg
- Housing: individual housing in suspended metal cages
- Diet (e.g. ad libitum): Free access to food (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol) was allowed throughout the study.
- Water (e.g. ad libitum): free access to drinking water and food was allowed throughout the study.
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22°C
- Humidity (%): 41 - 43%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test material, moistened with 0.5 ml of distilled water
- Concentration (if solution): not specified - Duration of treatment / exposure:
- 4h
- Observation period:
- 24, 48 and 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch on the shorn skin
- Type of wrap if used: strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h after application
OBSERVATION TIME POINTS
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later
SCORING SYSTEM:
- Scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
- Method of calculation: The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by 6 to give the primary irritation index of the test material. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The 2-(Naphthalen-2-sulfonylamino)benzoic acid did not produce positive criteria in any rabbit according to the EC labelling regulations and was classified as NON-IRRITANT to rabbit skin.
- Executive summary:
Study was performed to assess the irritancy potential of 2-(Naphthalen-2-sulfonylamino)benzoic acid following a single, 4-hour, semi-occluded application on New Zealand White rabbit following OECD guideline number 204 of 1981. 2-(Naphthalen-2 -sulfonylamino)benzoic acid did not produce positive criteria in any rabbit according to the EC labelling regulations and was classified as NON-IRRITANT to rabbit skin.
Reference
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 February 1992 to 21 February 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test material was used as provided - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.77 kg
- Housing: individual housing in a suspended metal cage
- Diet (e.g. ad libitum): free access throughout the study (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol)
- Water (e.g. ad libitum): free access throughout the study
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 50 - 56%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test material (approximately 59 mg)
- Concentration (if solution): not specified
- Control: left eye remained untreated and was used for control purposes - Duration of treatment / exposure:
- 48h
- Observation period (in vivo):
- 1h, 24h, 48 h
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24 and 48 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").
TOOL USED TO ASSESS SCORE: standard ophthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 15
- Max. score:
- 40
- Reversibility:
- other: Not reversible. due to persistence of opacy (grade of 4), the animals were killed after the 48h observation period.
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 40
- Max. score:
- 40
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: due to persistence of opacy (grade of 4), the animals were killed after the 48h observation period.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: due to persistence of opacy (grade of 4), the animals were killed after the 48h observation period.
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Residual test material was noted around the treated eye one hour after treatment.
Areas of diffuse corneal opacity were noted in the treated eye one hour after treatment. A small area, approximately 5 mm x 5mm, of grade 4 corneal opacity was noted in the treated eye at the 24 and 48-hour observations with diffuse to translucent corneal opacity in the remaining affected area of the treated eye.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations. Adherence of the test material to the nictitating membrane and lower conjunctival membrane was also noted at the 24 and 48-hour observations.
Due to the persistance of the grade 4 opacity the animal was killed for humane reasons immediately after the 48-hour observation in accordance with current U.K. Home Office guidelines. No further animals were treated. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test was only carried out with one animal and is therefore insufficient for classification, but the evidence shows that 2 -(Naphtalene-2'-sulphonylamino)-benzoic acid could be classified according to EC labeling regulations, into Category 1 - producing serious eye damage.
- Executive summary:
A study was performed to assess the irritancy potential of the 2 -(Naphtalene-2'-sulphonylamino)-benzoic acid to the eye of the New Zealand White rabbit, following the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" of 1987. A single application of the test material to the non-irrigated eye of one rabbit produced grade 4 corneal opacity, iridial inflammation and moderate conjunctival irritation. Although the test was only carried out with one animal and is therefore insufficient for classification, the evidence shows, that the test material could be classified according to EC labeling regulations into Category 1 - producing serious eye damage.
Reference
For information, the individual scores and total scores on tested rabbit are provided below:
Time after treatment |
1h |
24h |
48h |
|
Cornea |
||||
E = degree of opacity |
1 |
4ab |
4ab |
|
F = area of oapacity |
3 |
2 |
2 |
|
Score (ExF)x5 |
15 |
40 |
40 |
|
Iris |
||||
D |
1 |
1 |
1 |
|
Score (Dx5) |
5 |
5 |
5 |
|
Conjunctivae |
||||
A = Redness |
2 |
2tm |
2tm |
|
B = Chemosis |
2 |
2b |
2b |
|
C = Discharge |
3RE |
3 |
3 |
|
Score (A+B+C)x2 |
14 |
14 |
14 |
|
Total score |
34 |
59 |
59 |
|
a = grade 4 opacity over small area (5mm x 5mm) with grade 1 or 2 opacity over remainder of affected area
b = positive critria
tm = test material adhered to nictitating membrane and lower conjunctival membrane
RE = residual test material around treated eye
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for classification or non-classification
- Not classified for skin corrosion/irriation
- Serious eye damage - category 1 (based on corneal opacy of 4 at 24 and 48h after instillation of the test material)
2-(Naphthalene-2'-sulfonylamino)-benzoic acid is classified as follows according to CLP criteria:
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.