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EC number: 200-293-7 | CAS number: 56-86-0
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:
- 1 994
- 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
- Reference substance name:
- Glutamic acid
- EC Number:
- 200-293-7
- EC Name:
- Glutamic acid
- Cas Number:
- 56-86-0
- Molecular formula:
- C5H9NO4
- IUPAC Name:
- glutamic acid
- Details on test material:
- - Name of test material (as cited in study report): L-glutamic acid
- Physical state: white crystalline powder
- Stability under test conditions: Stable for duration of the study (2 years)
- Storage condition of test material: 4 degrees C in the dark
Constituent 1
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: 11 to 15 weeks
- Weight at study initiation: 2.6 to 3.4 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: no, the contralateral eye remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 60 mg of the test substance, 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:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Ocular irritation was assessed using the prescribed numerical system.
TOOL USED TO ASSESS SCORE: handheld lamp
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
- Remarks on result:
- other: Dulling one hour after instillation only
- 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:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- 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
- Remarks on result:
- other: Dulling one hour after instillation only
- 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
- Reversibility:
- fully reversible within: 1 day
- 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
- Remarks on result:
- other: Dulling one hour after instillation only
- 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:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Dulling of the normal lustre of the cornea was seen in all three animals one hour after instillation only.
No 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 or three days after instillation.
The eyes were normal two or three 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:
- Instillation of L-glutamic acid into the rabbit eye elicited dulling of the normal lustre of the cornea and transient well-defined conjunctival irritation.
All reactions had resolved two or three days after instillation.
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