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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
end on 8 July 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: screening test, sufficiently described

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
screening test, only one animal used
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
EC Number:
273-992-8
EC Name:
Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
Cas Number:
69416-61-1
Molecular formula:
C13H15NO5.K
IUPAC Name:
potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
Details on test material:
- Name of test material (as cited in study report): FGH-KZ
- Substance type: monoconstituent substance
- Physical state: data not available
- Analytical purity: data not available
- Impurities (identity and concentrations): data not available
- Purity test date: data not available
- Lot/batch No.: 1109 A
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source, Age at study initiation, Weight at study initiation, Fasting period before study, Housing, Diet, Water, Acclimation period: data not available

ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data not available

IN-LIFE DATES: data not available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 50 mg (specific gravity: 0.5)
- Concentration: undiluted
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
one animal
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize scale, according to OECD guideline

TOOL USED TO ASSESS SCORE: data not available

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean value (24, 48, 72h)
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean value (24, 48, 72h)
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean value (24, 48, 72h)
Score:
ca. 2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean value (24, 48, 72h)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Irritation of the conjunctival tissues was observed, which had resolved within 14 days after instillation of FGH-KZ.
Other effects:
lacrimation was observed after 1 and 48 hours.

Any other information on results incl. tables

Table 1: Irritant/corrosive response

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0

0

2

2

24 h

0

0

2

1

48 h

0

0

2

1

72 h

0

0

3

1

7 days

0

0

2

0

14 days

0

0

0

0

Average 24h, 48h, 72h

0

0

2.4

1

Reversibility*)

-

-

yes

yes

Average time (unit) for reversion

-

-

After 14 days

After 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
HPG-ds is irritating to the eyes according to EU criteria (CLP regulation)
Executive summary:

In a primary eye irritation study, 50 mg of undiluted HPG-ds (potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate) was instilled into the conjunctival sac of one eye of an albino rabbit (New Zealand White) after gently pulling the lower lid away from the eyeball. The lids were gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Irritation was scored by the method of Draize.

 

Irritation of the conjunctival tissues was observed, which had resolved within 14 days after instillation of FGH-KZ. According to the EEC criteria for classification and labelling requirements, the mean value of the scores for each type of lesion is the following (mean of 24, 48 and 72h):

-      Corneal opacity: 0

-      Iris: 0

-      Conjunctivae (redness): 2.3

-      Conjunctivae (chemosis): 1

 

In this study, HPG-ds (potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate) is an eye irritant based on EU criteria (according to CLP regulation).

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