Sulfonic acids, C14-17-sec-alkane, sodium salts

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:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Hostapur SAS 30

IUPAC Name:

Hostapur SAS 30

Constituent 3

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:

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

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h, 7 days

Score:

> 2 - <= 3

Max. score:

3

Reversibility:

not reversible

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h, 7 days

Score:

>= 2

Max. score:

2

Reversibility:

not reversible

Results 3

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

Results 4

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.