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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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

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.