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EC number: 200-293-7 | CAS number: 56-86-0
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 24, 1993 - January 10, 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.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The non-LLNA study was conducted before the validation of the LLNA
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 study
- Storage condition of test material: 4 degrees C in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 347g - 405g
- Housing: in groups of ten in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: water for irrigation
- Concentration / amount:
- Induction intradermal injection: 0.01% w/v in water for irrigation
Induction topical application: 70% w/v in distilled water. This was the maximum practical concentration that could be prepared and dosed topically
and did not give rise to irritating effects.
Topical challenge: 70 and 35% w/v in distilled water. From preliminary investigations 70% w/v in distilled water was the maximum practical
concentration and did not give rise to irritating effects.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water for irrigation
- Concentration / amount:
- Induction intradermal injection: 0.01% w/v in water for irrigation
Induction topical application: 70% w/v in distilled water. This was the maximum practical concentration that could be prepared and dosed topically
and did not give rise to irritating effects.
Topical challenge: 70 and 35% w/v in distilled water. From preliminary investigations 70% w/v in distilled water was the maximum practical
concentration and did not give rise to irritating effects.
- No. of animals per dose:
- 5 control animals
10 test animals - Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to indentify where possible (a) concentrations of
the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration
by the topical route of administration for the challenge phase.
MAIN STUDY
A. INDUCTION INTRADERMAL INJECTIONS
- No. of exposures: three pairs
- Exposure period: 6 days
- Test groups: 0.1 ml Freund's complete adjuvant was diluted with an equal volume of water for irrigation, 0.1 ml 0.01% w/v L-glutamic acid
in water for irrigation, 0.1 ml 0.01% w/v L-glutamic acid in a 50:50 mixture of Freund's complete adjuvant and water for irrigation
- Control group: were treated simirlarly to the test animals with the exception that the test substance was omitted from the intradermal injections
- Site: 40x60 mm area of dorsal skin on the scapular region
B. INDUCTION TOPICAL APPLICATION (ONE WEEK LATER)
- No. of exposures: three pairs
- Exposure period: 48 hours
- Test groups: 0.4 ml of 70% w/v L-glutamic acid in distilled water
- Control group: were treated simirlarly to the test animals with the exception that the test substance was omitted from the topical application
- Site: the same 40x60 mm area of dorsal skin on the scapular region
C. CHALLENGE EXPOSURE
- No. of exposures: the control and test animals
- Day(s) of challenge: two weeks after the topical induction
- Exposure period: 24 hours
- Test groups: 0.2 ml of 70% w/v L-glutamic acid in distilled water and applied to an anterior site on the flank, 0.2 ml of 35% w/v
L-glutamic acid in distilled water and applied to a posterior site on the flank
- Site: 20x20 mm on the left flank
- Evaluation (hr after challenge): 24, 48 and 72 hours after removal of the patches - Challenge controls:
- See details on study designs C. CHALLENGE EXPOSURE
- Positive control substance(s):
- yes
- Remarks:
- The guinea-pig strain is checked periodically with formalin
Results and discussion
- Positive control results:
- See section remarks on results including tables and figures
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Freund's treated controls
- Dose level:
- Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Freund's treated controls. Dose level: Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: Freund's treated controls
- Dose level:
- Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Freund's treated controls. Dose level: Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- other: Freund's treated controls
- Dose level:
- Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 72.0. Group: other: Freund's treated controls. Dose level: Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Freund's treated controls
- Dose level:
- Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Freund's treated controls. Dose level: Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: Freund's treated controls
- Dose level:
- Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Freund's treated controls. Dose level: Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- other: Freund's treated controls
- Dose level:
- Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 72.0. Group: other: Freund's treated controls. Dose level: Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: Anterior site, exposed to L-glutamic acid, 70% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded .
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded .
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: Posterior site, exposed to L-glutamic acid, 35% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: No signs of ill health or toxicity were recorded.
Any other information on results incl. tables
Summary of positive control data
Magnusson and Kligman test using formalin
M&K R&D No |
Number of Female animals |
Dates of study |
Dates of receipt of formalin |
Dose levels % (aqueous dilutions) |
Results |
|||||||
Induction |
Challenge |
|||||||||||
Test |
Control |
Start |
Finish |
Intradermal |
Topical |
|
Positive |
Inconclusive |
Negative |
|||
26 |
10 |
10 |
18.01.88 |
12.02.88 |
05.08.87 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
27 |
10 |
10 |
21.07.88 |
15.08.88 |
13.05.88 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28 |
10 |
10 |
10.01.89 |
04.02.89 |
16.12.88 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
29 |
10 |
10 |
17.07.89 |
11.08.89 |
15.05.89 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
30 |
I 10 |
10 |
31.10.89 |
25.11.89 |
15.05.89 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
10 |
10 |
16.01.90 |
10.02.90 |
29.11.89 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
32 |
10 |
10 |
23.07.90 |
24.09.90 |
04.07.90 |
0.05 |
5 |
3 and 1.5 |
5/10 |
0/10 |
5/10 |
|
|
|
|
|
|
|
|
|
5 and 3* |
10/10 |
0/10 |
0/10 |
|
33 |
10 |
10 |
30.10.90 |
24.11.90 |
04.07.90 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34 |
10 |
10 |
15.01.91 |
09.02.91 |
09.01.91 |
0.1 |
10 |
5 and 1 |
8/10 |
1/10 |
1/10 |
|
35 |
10 |
10 |
06.03.91 |
31.03.91 |
09.01.91 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
36 |
10 |
10 |
12..03.91 |
06.04.91 |
09.01.91 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
37 |
10 |
10 |
15.08.91 |
09.09.91 |
19.06.91 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
38 |
10 |
10 |
26.11.91 |
21.12.91 |
19.06.91 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39 |
10 |
10 |
10.02.92 |
13.03.92 |
09.01.92 |
0.1 |
10 |
5 and 1 |
7/10 |
0/10 |
3/10 |
|
|
|
|
|
|
|
|
|
5 and 1* |
10/10 |
0/10 |
0/10 |
|
40 |
10 |
10 |
13.08.92 |
08.09.92 |
29.06.92 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41 |
10 |
10 |
19.01.93 |
13.02.93 |
07.12.92 |
0.1 |
10 |
5 and 1 |
10/10 |
0/10 |
0/10 |
|
All animals supplied by D. Hall, Newchurch,Staffordshire,England
I Animals supplied by Interfauna, Huntingdon,Cambridgeshire,England
Formalin obtained from Savory andMoore, Huntingdon,Cambridgeshire,England, Thorton and Ross,Huddersfield,Englandor J.M. Loveridge plc,
Southhampton,England
* Second challenge
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this study, L-glutamic acid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test animals.
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