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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
15 April 2013 to 25 April 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,1 g of the test item
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1 hour
Score:
12
Max. score:
110
Reversibility:
fully reversible within: 1 day
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 1 hour
Score:
14
Max. score:
110
Reversibility:
fully reversible within: 3 days
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 48 h
Score:
2
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 72 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 1 hour
Score:
14
Max. score:
110
Reversibility:
fully reversible within: 3 days
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 24 h
Score:
4
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 48 h
Score:
2
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 72 h
Score:
0
Max. score:
110
Other effects:
The conjunctivae reactions obseved during the study have been moderate and totally reversible.
A pink colloration on the nictitating membrane was noted at the reading time 1 hour, was totally reversible on day 2 in one animal and remained on day 3 in two animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item does not have to be classified. No signal word or hazard statement is required.