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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
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
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

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