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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
not available
Molecular formula:
C13 H17 Cl2 N O2 HCl
IUPAC Name:
not available
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
2-(ter-butylamino)-1-(3-chloro-4-hydroxy-5-chloromethylphenyl)ethanone HCl

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1g
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 #2 #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 5 days (animal 2)
Remarks:
no irritation for animal 1 and 3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1 #2 #3
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
3
Reversibility:
fully reversible within: 14 days (animal 1); 7days (animal 2); 10 days (animal 3)
Irritation parameter:
iris score
Basis:
animal: #1 #2 #3
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
2
Reversibility:
other: N.A.
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1 #2 #3
Time point:
24/48/72 h
Score:
>= 1 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 7 days (animal 1); 5 days (animal 2); 10 days (animal 3)
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal: #1 #2 #3
Time point:
24/48/72 h
Score:
>= 0 - <= 2
Max. score:
3
Reversibility:
fully reversible within: 6 days (animal 1); 3 days (animal 2); 3 days (animal 3)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
the substance produced irritating effects, which were reversile, but no corrosion.