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EC number: 229-319-5 | CAS number: 6471-78-9
- 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 November 14th to November 21st, 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study GLP compliant and conducted according to internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Kresidinsulfosäure
- IUPAC Name:
- Kresidinsulfosäure
- Reference substance name:
- 5-methoxy-2-methylsulphanilic acid
- EC Number:
- 229-319-5
- EC Name:
- 5-methoxy-2-methylsulphanilic acid
- Cas Number:
- 6471-78-9
- Molecular formula:
- C8H11NO4S
- IUPAC Name:
- 5-methoxy-2-methylsulphanilic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.6 kg
- Housing: in air-conditions room in individual cages
- Diet: ad libitum with maintenance diet for rabbit and hay (about 15 g daily)
- Water: deionized and chlorinated water from automatic soak ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The animals were housed in an air-conditioned room at a temperature of 20 ± 3°C
- Humidity (%): 50 ± 20 %.
- Photoperiod (hrs dark / hrs light): The light/dark cycle was 12 hours per day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 100 mg in left eye - Observation period (in vivo):
- 7 days. The effects were recorded after 1h, 24h, 48h and till 7 days after treatment.
- Number of animals or in vitro replicates:
- One rabbit
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):24 hours after testing the treated eye was washed with saline solution.
TOOL USED TO ASSESS SCORE: For the assessment of damages a drop of sodium fluorescein solution (0.01%) were put in the eye and the eye was examined by UV-light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eye rinsed. The data for 72h was extrapolated by data for 48h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eye rinsed. The data for 72h was extrapolated by data for 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24h , 48h, 72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eye rinsed. The data for 72h was extrapolated by data for 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eye rinsed. The data for 72h was extrapolated by data for 48h
- Other effects:
- One hour after the application hyperemia and a clear swelling of the conjunctiva appeared.
From day 1 to day 7 a diffuse redness and swelling with half or more than half closed eyelids were observed as well as cornea discharge, nictitating membrane and the conjunctiva .
On day 7 diffuse vascularization was present as result of treatment.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on precautionary principle the substance 5-methoxy-2-methylsulphanilic acid is classified H318 (Causes serious eye damage) according to CLP Regulation (EC n. 1272/2008).
- Executive summary:
Based on precautionary principle the substance 5-methoxy-2-methylsulphanilic acid is classified H318 (Causes serious eye damage) according to CLP Regulation (EC n. 1272/2008).
In fact, the test of eye irritation was conducted only on one rabbit but as reported in OECD 405 if the resultant of the initial test on the first animal indicate the substance to be corrosive or a severe irritant to the eye using the further testing for ocular irritancy should not be perform. In fact, after application of 5-methoxy-2-methylsulphanilic acid on the first rabbit high level of cornea opacity (mean value:4 /max score: 4), extent redness of conjunctivae (mean value:2 /max score: 3) and big swelling or chemosis (mean value:4 /max value:4) in the treated eye were observed and all these effect are not fully reversible within 7 days. The treated eye was washed after 24h from application.
According to CLP Regulation(EC n. 1272/2008) the criteria to classified a substance as eye corrosive (cat.1) are:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 3 and/or
— iritis > 1,5
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
From this study for the substance 5-methoxy-2-methylsulphanilic acid the criteria to classified the substance as eye corrosive (cat.1) are not completely fullfilled (the effects are not fully reversible within 7 days but no information are available till 21 days and the mean of cornea opacity is greater than 3 but data are available only for one animal).
Based on severe effect observed on one rabbit and based on precautionary principle the substance 5-methoxy-2-methylsulphanilic acid is classified H318 (Causes serious eye damage) according to CLP Regulation (EC n. 1272/2008).
The applicant agrees with the author of the study that in 1989 classified the substance as R41 according to Directive 83/467/CEE (Note: Directive 83/467/CEE is an update of Directive 67/548/EEC). As reported in annex VII of CLP Regulation (EC n. 1272/2008) classification R41 according to Directive 67/548/EEC is equivalent to H318 according to CLP Regulation (EC n. 1272/2008).
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