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EC number: 307-055-2 | CAS number: 97489-15-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- EC Number:
- 307-055-2
- EC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Cas Number:
- 97489-15-1
- Molecular formula:
- H3C-(CH2)m-CH-(SO3Na)-(CH2)n-CH3
- IUPAC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Reference substance name:
- Hostapur SAS 30
- IUPAC Name:
- Hostapur SAS 30
- Reference substance name:
- Alkansulphonate
- IUPAC Name:
- Alkansulphonate
- Details on test material:
- - Name of test material (as cited in study report): Hostapur SAS 30
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: liquid
- Analytical purity: 30%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 30% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: 1989-01-13
- Lot/batch No.: 95468
- Expiration date of the lot/batch: 1991-02-01
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: 20°C, in darkness, in cupboard
- Other:
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: in house breeding
- Age at study initiation: 3 - 5 month
- Weight at study initiation: approximately 2.5 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours
IN-LIFE DATES: From: 1989-05-23 To: 1989-05-30
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0,1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h, 7 days
- Score:
- > 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h, 7 days
- Score:
- >= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h, 7 days
- Score:
- > 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h, 7 days
- Score:
- > 0 - <= 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Other effects:
- 7 days after application the treated eye of the rabbit exhibited a clear vascularisation.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: risk of serious damage to eyes
- Executive summary:
Sec-alkane sulfonate-sodium salts SAS (30%) was tested for primary eye irritation according to OECD 405 and GLP. Based on the observed skin irritating potential in rabbits, testing for eye irritation was conducted in only one rabbit. 0.1 mL of undilauted Hostapur SAS 30 was applied into the left conjunctival sac of this rabbit. The right eye served as a control. Assessments were made 1, 24, 48 and 72 hours p.a. as well as 7 days after treatment. From one hour up to seven days moderate irritations including corneal and iridial effects were observed. After seven days a clear vascularisation of the cornea was observed. Based on the results of this study, sec-alkane sulfonate-sodium salts SAS (30%) when tested according to OECD guideline 405 was considered to be severely irritating to eyes and thus no further animals were included in the test.
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