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Diss Factsheets

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:
2013
Report date:
2013
Reference Type:
study report
Title:
Unnamed
Year:
2010

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.