Registration Dossier
Registration Dossier
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EC number: 205-538-1 | CAS number: 142-47-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 7 - 10, 1993
- 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd, Petersfield, Hampshire, England
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: Individually in metal cages
- 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- other: no, comparison with adjacent untreated skin
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): gauze pad which had been moistened with 0.5 ml distilled water. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Day 1 (i.e. approximately 60 minutes after removal of the dressing)
Day 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure) - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 100 mm x 100 mm
- % coverage: 25
- Type of wrap if used: gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30 to 40 degrees C)
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Local dermal irritation was assessed using the prescribed numerical system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema 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:
- erythema score
- Basis:
- animal #2
- 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: 1 day
- Irritation parameter:
- erythema 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:
- edema 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:
- edema score
- Basis:
- animal #2
- 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: 1 day
- Irritation parameter:
- edema 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:
- Very slight erythema and oedema was seen in animal 2 following removal of the bandages. The reactions were of a barely perceptible nature and were seen on one occasion in one animal only. This isolated finding is not regarded as significant.
- 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:
- A single semi-occlusive application of Monosodium L-glutamate to intact rabbit skin for four hours elicited transient very slight dermal reactions.
The reactions were of a barely perceptible nature and were seen on one occasion in one animal only.
This isolated finding is not regarded as significant.
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