Supernatant from the crystallisation of L-threonine from the broth filtrate from the fermentative production of L-threonine

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Directive 92/32/EEC

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-Threonine mother liquor

IUPAC Name:

L-Threonine mother liquor

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.