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Registration Dossier
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EC number: 931-534-0 | CAS number: 68439-57-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Reference substance name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- EC Number:
- 931-534-0
- Cas Number:
- 68439-57-6
- Molecular formula:
- C(4+2n)H(9+4n)SO4Na C(4+2n)H(7+4n)SO4Na n = 5-6
- IUPAC Name:
- Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Hostapur OS Pulver; alpha-Olefinsulfonate, sodium salt
- Molecular weight (if other than submission substance): approx. 310
- Physical state: white powder
- Analytical purity: approx. 90 %
- Impurities (identity and concentrations): approx. 5 % Na2SO4, 3 % Na2CO3, 2 % residual oil
- Composition of test material, percentage of components: C-chainlengths: ≤ C12: max. 1 %, C14: approx. 65 %, C16: approx. 30 %, ≥ C18: max. 1.5 %
- Lot/batch No.: E0617179, dated 1984-06-05
- Storage condition of test material: dark at 22°C
- Other: Source: Hoechst AG
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Weight at study initiation: 2.9 - 3.2 kg
- Housing: individually
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbit, Altromin GmbH, Lage/Lippe, ad libitum
- Water (e.g. ad libitum): deionised chlorinated water, automatic supply, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- physiological saline
- Controls:
- other: untreated eyes served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg, moistened with physiological saline, into conjunctival sac of left eye
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.08 mL 0.9 % physiological saline - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 37°C warm physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: additionally fluorescein (0.01 %), UV light at 24 and 72 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: opacity becoming worse during observation period, score of "4" after 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: opacity becoming worse during observation period, score of "4" after 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: score of "2" after 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: score of "2" after 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Score of "2" after 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: score of "1" after 21 days
- Irritant / corrosive response data:
- Between 1 and 72 hours after application clearly injected vessels up to diffuse, beefy red erythemae and slight to severe swellings of the conjunctivae were observed. Furthermore, circumcorneal injection of the iris and corneal opacity were noticed. Additionally, the treated eyes demonstrated discharge, clear and colourless in the beginning, white and viscous later on.
One animal was free of symptoms after 7 days, the remaining 2 animals still suffered from distinct edema and erythema, ranging from diffuse, crimson red up to diffuse, beefy red. Additionally, white, viscous discharge was observed.
After 14 and 21 days these animals still demonstrated obvious edema and clearly injected vessels or diffuse, crimson red erythema of the conjunctivae, and complete corneal opacity with advanced vascularisation. - Other effects:
- none reported
Any other information on results incl. tables
Conclusion:
According to the criteria of the DSD and the CLP regulation the substance has to be considered as inducing "severe damage to the eyes" and would have to be classified as:
DSD: Xi, R41: Risk of serious damage to eyes
CLP: Eye Dam. 1, H318: Causes serious eye damage
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- EU Directive 67/548/EEC: Xi, R41
Regulation (EC) No 1272/2008: Eye Dam. 1, H318
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