Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline 405 (1987)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Directive 92/32/EEC
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Name of test material (as cited in study report): L-Threonine containing mother liquor
Details are presented in "Confidential details on test material"

Test animals / tissue source

Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
-Source: ASTA Medica AG, Halle, Germany
-Age at study initiation: 12 months
-Weight at study initiation: 2070 – 3410 g
-Housing: individually
-Certified diet ad libitum
-Tap water ad libitum
-Acclimation period: At least one day under test conditions before application of the test substance

ENVIRONMENTAL CONDITIONS
According to guideline

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye was not treated and acted as control.
Amount / concentration applied:
TEST MATERIAL
-Amount: 0.1 mL
-Concentration (if solution): undiluted
Duration of treatment / exposure:
eyes were not rinsed
Observation period (in vivo):
Scoring 1, 24, 48, and 72 h after instillation
Number of animals or in vitro replicates:
1 female and 2 males
Details on study design:
Application of 0.1 mL of the test substance into the conjunctival sac of the right eye.
Scoring: According to Guideline
Tool used to assess score: Varta Cliptrix diagnostic-lamp
Attention was paid also on the occurrence of clinical symptoms (systemic toxic effects)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
110
Remarks on result:
other: In one animal hyperemia of the conjunctiva was recorded at the application day.
Irritant / corrosive response data:
The primary irritation index was zero, i.e. the test substance caused no eye irritation in rabbits.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
L-Threonine mother liquor was tested for eye irritation in rabbits in a GLP study according to OECD guideline 405. The primary irritation index was zero, i.e. the test substance caused no eye irritation. There were also no clinical signs of systemic toxicity.