Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
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 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:
Chromodacryorrhoea and/or scales on the treated skin area were observed for several animals on Days 1 and 5, respectively.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
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.