Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-02-13 to 2007-02-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline 405 (adopted 2002)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Harlan Italy s.r.l.
Weight: ca. 2000 g
Age: 9 – 11 weeks
Acclimatisation period: at least 10 days
Housing: individually in stainless steel cages equipped with grid floor
Diet: STANRAB (P) SQC ad libitum
Water: ad libitum

Environmental conditions:
Temperature (°C): 19 ± 2
Relative humidity (%): 55 ± 15
Photoperiod (hrs dark / hrs light): 12 / 12 by fluorescent tubes
Air changes (per hr): 15-20

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
Amount applied: 100 mg
Duration of treatment / exposure:
Single application
Observation period (in vivo):
up to 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
No rinsing

SCORING SYSTEM
According to guideline

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Irritant / corrosive response data:
Slight redness, chemosis and discharge (scores of 1) were observed in the 3 animals at the 1 h examination. The ocular reactions were reversible in all animals within 24 h after application.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute eye irritation of L-tryptophan was investigated with rabbits in a GLP study according to OECD guideline 405. There was no indication of a systemic effect of treatment. Changes in body weight were not remarkable. A slight irritation was observed at the 1 h examination in all animals, but recovery occurred at the 24 h examination. Therefore, L-tryptophan can be classified as not eye irritating.