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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
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(naphthalene-2-sulfonamido)benzoic acid
- EC Number:
- 601-471-0
- Cas Number:
- 117309-52-1
- Molecular formula:
- C17H13NO4S
- IUPAC Name:
- 2-(naphthalene-2-sulfonamido)benzoic acid
- Test material form:
- solid
- Details on test material:
- Test material: NSABZ (2-(Naphthalene-2'-sulphonylamino)-benzoic acid)
Date of receipt: 20 December 1991.
Description: Very light brown powder.
Storage: In original container at room temperature.
Constituent 1
- 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
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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