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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1990-03-28 to 1990-04-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, used for read-across

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, Bielefeld, Germany
- Age at study initiation: males: 9 months; female: 9 months
- Weight at study initiation: males: 2.63 and 2.89 kg; female: 2.90 kg
- Caging: Stainless steel cages with grating floor, type ASTA
- Diet (e.g. ad libitum): ca. 120 g /day per animal Standard Diet ssniff K, "Special diet for rabbits", supplied by ssniff Spezialfutter GmbH
- Water (e.g. ad libitum): ad libitum
- Acclimation period: The animals were kept one day under test conditions before application of the product.

ENVIRONMENTAL CONDITIONS
- according to guideline

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.023 g
Duration of treatment / exposure:
Substance was not actively removed from the eye
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3; 2 males and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no rinsing
- Time after start of exposure: not actively removed

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours; 48 hours; 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours; 48 hours; 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours; 48 hours; 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Max. scores: (a) Redness: 3. (b) Chemosis: 4. (c) Discharge: 3. Total maxiumum = Σ(a+b+c)x2:12
Irritant / corrosive response data:
Conjunctivae reactions were limited to slight redness at 2 animals after 1 hour observation.
Other effects:
No other effects detected

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
L-Alanyl-L-glutamine was tested on three rabbits for eye irritation. The primary irritation index was 0.3. The substance was classified as non-irritant on the eye of the rabbit following a single application.