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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 March 1994 - 27 June 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
426-290-2
EC Name:
-
Cas Number:
74149-72-7
Molecular formula:
C20H20N2O7
IUPAC Name:
methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate
Details on test material:
- Name of test material (as cited in study report): UD-CG 115 Nitrobenzamide (Gamma-NAP)
- Substance type: monoconstituent
- Analytical purity: 98.9%
- Purity test date: 04 February 1994
- Lot/batch No.: 1/94
- Stability under test conditions: guaranteed until February 1996.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmBH, D-88397 Biberach
- Age at study initiation: males: 99 and 116 days; females: 86 and 92 days
- Weight at study initiation: 2.9 - 3.15 kg
- Housing: solid wire cages in an air-conditioned room
- Diet (e.g. ad libitum): dry food (in pellets Nafag, THOM 5) ad libitum
- Water (e.g. ad libitum): municipal drinking water
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-/ 3°C
- Humidity (%): 45 - 75%
- Air changes (per hr): maximum 16 x/h
- Photoperiod (hrs dark / hrs light): 9/15 hours

IN-LIFE DATES: From: 28 March 1994 To: 30 March 1994.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye of each rabbit served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3 (20 mg)
Duration of treatment / exposure:
The lids were held gently together for about one second in order to prevent loss of material.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4 rabbits (2 males and 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable (no reaction)
Irritant / corrosive response data:
No chemosis was observed in any animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritant after eye contact under the test conditions of the study.