Registration Dossier
Registration Dossier
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EC number: 200-293-7 | CAS number: 56-86-0
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: SIDS
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- SIDS for L-Glutamic acid
- Author:
- OECD
- Year:
- 2 013
- Report date:
- 2013
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Specific details on test material used for the study:
- Details on test material
- Name of test material: L-glutamic aicd
- Substance type: white powder
- Physical state: solid
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks old) were selected.
- Weight at study initiation: males 299-327g, female 187-204 g
- Fasting period before study: no
- Housing: Individually housed in labeled Macrolon cages containing sterilized sawdust as bedding material and paper as cage enrichment.
- Diet: free access to pelleted rodent diet
- Water: free access to tap water
- Acclimation period: a health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.
ENVIRONMENTAL CONDITIONS
- Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +/- 3.0℃, a relative humidity of 40-70% and 12 hours artificial fluorescent light and 12 hour darkness per day.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1% Aqueous carboxymethyl cellulose
- Details on dermal exposure:
- The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm2 for males and 18 cm2 females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminum foil and Coban elastic bandage. A piece of Microspore tape was additionally used for fixation of the bandages in females only.
- Duration of exposure:
- 24 h
- Doses:
- 2,000 mg/kg (10mL/kg) bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations
Mortality/Viability: Twice daily
Body weights: Days 1, 8 and 15Clinical signs: At periodic intervals on the day of dosing and once daily thereafter, until day 15.
Necropsy: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy.
Descriptions of all internal macroscopic abnormalities were recorded
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Chromodacryorrhoea and/or scales on the treated skin area were observed for several animals on Days 1 and 5, respectively.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 value of L-glutamic acid in rats was greater than 2,000 mg/kg bw.
L-Glutaminic acid is not classified as toxic via dermal route.
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