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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 20, 1993 - January 11, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to EC guidelines and according to GLP principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hydrogen glutamate
EC Number:
205-538-1
EC Name:
Sodium hydrogen glutamate
Cas Number:
142-47-2
Molecular formula:
C5H8NNaO4
IUPAC Name:
sodium hydrogen 2-aminopentanedioate
Details on test material:
- Name of test material (as cited in study report): Monosodium L-glutamate
- Substance type: hydrated form.
- Physical state: white crystals
- Stability under test conditions: stable for duration of the study (2 years)
- Storage condition of test material: 4 degrees C in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.7 to 3.2 kg
- Housing: individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: all rabbits were acclimatised to the experimental environment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 70 mg (the weight occupying a volume of 0.1 ml)
Duration of treatment / exposure:
7 days after instillation.
Observation period (in vivo):
1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation.
Number of animals or in vitro replicates:
1 male and 2 females.
Details on study design:
SCORING SYSTEM: Ocular irritation was assessed using the prescribed numerical system.

TOOL USED TO ASSESS SCORE: handheld light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed.
A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids was seen in all three animals one hour after instillation. These reactions gradually ameliorated and had resolved completely two days after instillation.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Installation of monosodium L-glutamate into the rabbit eye elicited transient well-defined conjunctival irritation.
All reactions had resolved two days after instillation.