Registration Dossier

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:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate
Molecular formula:
C11 H17 N3 O6 . 3H2O
IUPAC Name:
(6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test item SND 919 Precursor 3a, applied to the rabbits` eye micosa, caused irritant effects, which can be evaluated as fully reversible within 24h. According to the EC criteria for classification and labbeling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.