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EC number: 939-368-0 | CAS number: -
- 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 11 March 1994 to 29 June 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is sufficiently documented. No certificate of analysis is available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium isopropylnaphtalene sulfonate
- IUPAC Name:
- sodium isopropylnaphtalene sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- See confidential details on test material section
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: Animals were received from Ace Animals on 1/18, 2/15 and 2/22/94.
- Age at study initiation: The animals were born the week of 10/24 through 12/12/93.
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet # 5321)
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: three days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): No data on temperature but the animal room was temperature controlled.
- Humidity (%): data not available
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: data not available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL:
- Amount applied (volume or weight with unit): 0.1 ml equivalent of test material introduced into the conjunctival sac of the each eye
- Concentration (if solution): not applicable
- pH: no applicable
VEHICLE: / - Duration of treatment / exposure:
- Single conjunctival instillation
- Observation period (in vivo):
- 1 hour, and days 1, 2, 3 and 7 after the instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : 20-30 seconds after instillation of the test article, the left eye of each rabbit was flushed for one minute with lukewarm water. The right eye of each animal remained unwashed.
SCORING SYSTEM: The eyes were examined and scored by the Draize technique at 1 hour post dose and again on days 1, 2, 3 and 7 post dose.
TOOL USED TO ASSESS SCORE: data not available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1.33 - <= 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 2.0, 1.33 and 1.33 for corneal opacity.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- at day 7
- Remarks on result:
- other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.0 for iris lesions.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 2.7
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- at day 7 for 1 animals
- Remarks on result:
- other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 2.7, 2.0 and 2.0 for redness of the conjunctiva
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2.33 - <= 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 3.0, 2.33 and 3.0 for chemosis.
- Irritant / corrosive response data:
- Unwashed: Corneal opacity, noted in 3/3 eyes, persisted up to day 7. Iritis, noted in 3/3 eyes, cleared by day 7. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye and improved to slight in two eyes.
Washed: Corneal opacity was noted in two eyes on day 7. Iritis, noted in 3/3 eyes, persisted up to day 7 in one eye. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye, cleared in one eye and improved to slight in the third eye. - Other effects:
- There were no signs of systemic toxicity noted during the observation period.
Any other information on results incl. tables
Result Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Unwashed right eye:
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
2/0h/0h |
1/1/1 |
2/2/2 |
3/3/3 |
24 h |
2/0h/0h |
1/1/1 |
2/2/2 |
3/3/3 |
48 h |
2/2/2 |
1/1/1 |
3/2/2 |
3/2/3 |
72 h |
2/2/2 |
1/1/1 |
3/2/2 |
3/2/3 |
Average 24h, 48h, 72h |
2/1.33/1.33 |
1/1/1 |
2.7/2/2 |
3/2.33/3 |
Reversibility*) |
n. |
c. |
n.c. |
n. |
Average time (unit) for reversion |
- |
Day 7 |
Day 7 (2/3 eyes) |
- |
*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible
h: lack of normal luster
Washed left eye:
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
1/1/2 |
2/3/3 |
24 h |
0h/0h/0h |
0/1/0 |
2/2/2 |
2/3/3 |
48 h |
0h/0h/0h |
1/1/0 |
3/2/2 |
2/3/3 |
72 h |
0h/0h/0h |
1/1/0 |
3/2/2 |
2/3/3 |
Average 24h, 48h, 72h |
0/0/0 |
0.66/1/0 |
2.66/2/2 |
2/3/3 |
Reversibility*) |
n.c. (score :2 in 2 animals at day 7) |
n.c. (score :1 in 1 animal at day 7) |
n.c. (score : 1 and 2 in 2 animals at day 7) |
n.c. (score :2 in 1 animal at day 7) |
Average time (unit) for reversion |
- |
- |
- |
- |
*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible
h: lack of normal luster
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the test item was found severely irritating to the eye of rabbit. Based on these results, the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is classified Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE, and Eye Damage Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eye damages at the end of the observation period (7 days).
- Executive summary:
In a primary eye irritation study (1994), 0.1 ml equivalent of the test article was instilled into the conjunctival sac of each eye of New Zealand Albino rabbits (3 animals). 20-30 seconds after instillation of the test article, the left eye of each rabbit was flushed for one minute with lukewarm water. The right eye of each animal remained unwashed. Animals were then observed for 7 days. Irritation was scored by the method of Draize.
For unwashed eyes : Corneal opacity, noted in 3/3 eyes, persisted up to day 7. Iritis, noted in 3/3 eyes, cleared by day 7. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye and improved to slight in two eyes.
Mean scores calculated for each animal over 24, 48 and 72 hours were 2.0, 1.33 and 1.33 for corneal opacity; 1.0, 1.0 and 1.0 for iris lesions; 2.7, 2.0 and 2.0 for redness of the conjunctiva and 3.0, 2.33 and 3.0 for chemosis.
For washed eyes: Corneal opacity was noted in two eyes on day 7. Iritis, noted in 3/3 eyes, persisted up to day 7 in one eye. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye, cleared in one eye and improved to slight in the third eye.
Under the experimental conditions of this study, the test item was found severely irritating to the eye of rabbit. Based on these results, the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is classified Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE and Eye Damage, Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eyes damages at the end of the observation period (7 days).
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