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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27.7.2006.-3.1.2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
An in vitro eye irritation study need does not to be conducted because adequate data from an in vivo eye irritation study are available.
Cross-reference
Reason / purpose for cross-reference:
exposure-related information
Reference
Name:
Fain
Implementation:
EU
Type of classification:
harmonised classification
Remarks:

Serious eye damage/eye irritation is classified as category 2b( Causes eye irritation) in GHS , but the category is not used is CLP, where the classification is

considered to be category 2 (Causes serious eye irritation)=> Warning! H319: Causes serious eye irritation.

Related composition:
Fain
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
hazard class not assessed
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Hazard category:
Eye Irrit. 2B
Hazard statement:
H320: Causes eye irritation.
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Signal word:
Warning
Code:
GHS07: exclamation mark
Hazard statement:
H319: Causes serious eye irritation.
Precautionary statement:
P264: Wash ... thoroughly after handling.
Additional text:
hands
Precautionary statement:
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
Precautionary statement:
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Precautionary statement:
P337+P313: If eye irritation persists: Get medical advice/attention.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
EC Number:
288-492-5
EC Name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
Cas Number:
85736-79-4
Molecular formula:
Sulfonic acid, C13-17-sec-alkane: C13H28O3S (MW 264,42) - C17H36O3S (MW 320,53) and 2,2',2''-nitrilotriethan: C6H15NO3 (MW 149,19) , typical medium molecular weight of mixture 454 g/mol.
IUPAC Name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
Test material form:
liquid: viscous
Specific details on test material used for the study:
Fain, Batch 06244

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0,1 ml
Duration of treatment / exposure:
Eyelids were kept closed for a
Observation period (in vivo):
7 days
Details on study design:
See full report.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
7 d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
7 d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See full report for additional data.

Any other information on results incl. tables

Chemosis, Conjunctivea, Iris and Cornea were tested. See full report, appendix 1 (Page 17) for full results.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
The results met the category 2b result based on GHS criteria.
Executive summary:

The results met the category 2b result based on GHS criteria.