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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14, ethoxylated, sulfates, sodium salts
EC Number:
500-234-8
EC Name:
Alcohols, C12-14, ethoxylated, sulfates, sodium salts
Cas Number:
68891-38-3
Molecular formula:
not applicable, UVCB
IUPAC Name:
Alcohols, C12-14(even numbered), ethoxylated < 2.5 EO, sulfates, sodium salts

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
Amount: 0.1 mL
Concentration: 20% (5.4% a.i.)
Duration of treatment / exposure:
single administration without washing
Observation period (in vivo):
7 days
Observation time points: 1, 24, 48 and 72 h after administration
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Cornea and iris were normal.
Conjunctiva redness and swelling appeared after 60 minutes. Swelling disappeared in part in 2 animals after 24 hours and in all after 7 days. Redness disappeared completely after 24 hours.
For individual animal responses, please refer to Table 1 under "any other information on results incl. tables."

Any other information on results incl. tables

Table 1: Results of the eye irritation study

 

Rabbit # Time conjunctivae   iris cornea
redness swelling
1 1 h 3 1 0 0
24 h 2 0 0 0
48 h 1 0 0 0
72 h 1 0 0 0
7 d 0 0 0 0
average 1.3 0.0 0.0 0.0
2 1 h 3 1 0 0
24 h 3 0 0 0
48 h 1 0 0 0
72 h 1 0 0 0
7 d 0 0 0 0
average 1.7 0.0 0.0 0.0
3 1 h 3 1 0 0
24 h 2 0 0 0
48 h 0 0 0 0
72 h 0 0 0 0
7 d 0 0 0 0
average 0.5 0.0 0.0 0.0

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
In the present in vivo eye irritation study in rabbits, the test substance produced weak irritation symptoms in the conjunctiva of the tested animals. The reactions were fully reversible within 7 days. Based on the obtained scores which were below the cut-off values for a positive response, the test substance was concluded not to be irritant to the eye.