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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 92/69, Annex V - Method B4 and OECD No. 404.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: The test substance was applied undiluted
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1ml
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
1 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 1, 24, 48, and 72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 1, 24, 48, and 72 h
Score:
0
Max. score:
1
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #2
Remarks:
(mean scroe 2)
Time point:
other: overall at 1, 24, 48, and 72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
other: Redness
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 1, 24, 48, and 72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritant / corrosive response data:
A very slight redness of the conjunctiva was observed in one animal on day 1 only. No other ocular reactions were noted during the study. Mean scores calculated for each animal over 1, 24, 48, and 72 hours were 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.

Applicant's summary and conclusion

Executive summary:

Under the experimental conditions, Pseudo Kharismal Step 1 is non-irritant when administered by ocular route to rabbits.