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EC number: 285-597-8 | CAS number: 85117-47-1
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- 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
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:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to guidelines and GLP.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sgarlat's Rabbitry, PA
- Weight at study initiation: 2.9-3.1 kg
- Housing: 1 animal/cage in suspended wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/rabbit - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Mean score calculated by average of results at 24h, 48h, and 72 h for each animal.
- Other effects:
- Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of sodium 4-icosylbenzenesulfonate for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Oedema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
1/0/1 |
0/0/1 |
24 h |
1/0/1 |
0/0/1 |
48 h |
1/0/2 |
0/0/1 |
72 h |
0/0/2 |
0/0/1 |
Average 24h, 48h, 72h |
0.7/1/0.7 |
0.3/0.3/0.3 |
Reversibility*) |
c/c/c |
c/c/c |
Average time (unit) for reversion |
72/0/14d |
0/0/14d |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study to GLP.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2141 to 2331 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): Certified Rabbit Lab diet 150 g/day
- Water (e.g. ad libitum): as libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 30.2 - 48.5%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle - 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 - Duration of treatment / exposure:
- Eyelids of animals were held closed for one second after installation.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours following dosing and on day 4.
- Number of animals or in vitro replicates:
- 3 male/3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed exposure
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein - Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 5
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 5
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 1, 2, 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 4, 5, 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- One animal had clear discharge from the eye, one hour post dosing. There were no deaths or changes in bodyweight throughout the study.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Score for conjunctival rednes and oedema werer less than 2 in all of the animals. Therefore, this substance is not irritating to rabbit eyes.
- Executive summary:
In a primary eye irritation study 0.1 ml of sodium 4-icosylbenzenesulfonate was instilled into the conjunctival sac of young adultwhite rabbits (3/sex). Animals then were observed for 7 days. Irritation was scored by the method of Draize.
No eye irritation was observed. In this study, sodium 4-icosylbenzenesulfonate is not an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
All available skin irritation and eye irritation data available demonstrate that the substance tested was not
irritating to skin or eyes.
Data are presented only using in vivo methods as these data were available for the substance. In vitro data are
considered not justifiable scientifically or by expense as the data are not likely to provide any additional
contribution to the conclusion available from the in vivo data.
Justification for selection of skin irritation / corrosion endpoint:
In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of sodium 4-icosylbenzenesulfonate for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.
Justification for selection of eye irritation endpoint:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Score for conjunctival rednes and oedema werer less than 2 in all of the animals. Therefore, this substance is not irritating to rabbit eyes.
Justification for classification or non-classification
Based on the data available for skin and eye irritation, exposure to the substance gives rise to no adverse
reactions. The substance is, therefore, considered to be not irritating to skin or eyes.
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.
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