Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-2-tert-butoxycarbonylamino-3-hydroxy propionic acid
EC Number:
613-313-8
Cas Number:
6368-20-3
Molecular formula:
C8H15NO5
IUPAC Name:
(R)-2-tert-butoxycarbonylamino-3-hydroxy propionic acid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
other: Other eye of the animal
Duration of treatment / exposure:
0,1 g of test item were instilled into the conjunctival sac of one eye of each animal.
After an exposure period of 24h the treated eyes were rinsed with deionised water.
Observation period (in vivo):
The conjunctivae, cornea and iris of the eyes were examined at 1, 24, 48 and 72 hours and from day 4 to day 21 after instillation.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Score:
>= 3
Irritation parameter:
iris score
Score:
ca. 2

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
H318 - Causes serious eye damage.