Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Purity and physicochemical properties of test substance not given, sex, strain, and age of test animals not given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
scoring according to Draize
Deviations:
yes
Remarks:
no one hour scoring, no use of anaesthetics, separate groups of 3 animals with eyes washed at 2 or 4 seconds after application
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
Dechlorane Plus was tested as supplied

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No details reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
applied to eyes and not washed - maximum 24 hours until first examination
applied to eyes and washed - 2 or 4 seconds
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 groups of 3 animals each
Details on study design:
Application to right eyes, left eyes served as controls, 0.1 ml applied undiluted, in one group each the eyes were washed after 2 and 4 seconds, one group remained unwashed, 3 rabbits per group, recording of irritant effects according to Draize after 24, 48, and 72 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
not irritant
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the provisions of regulation 1272/2008, Annex I, 3.3, Dechlorane Plus is not classified as irritating to rabbit eyes.
Executive summary:

Groups of 3 rabbits each were applied with 0.1 ml of Dechlorane Plus undeluted into the right eye, while the left eye served as control. In two groups, the treated eyes were washed after 2 or 4 seconds. The reactions were recorded at 24, 48, and 72 hours after application according to Draize. No irritant effect at all was observed in any animal at any time point. Dechlorane Plus was completely non irritant.