L-Glutamic acid, N-acetyl-, compd. with (.alpha.S)-.alpha.-(2-methylpropyl)-2-(1-piperidinyl)benzenemethanamine (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 April - 7 May 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: In compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Principles of Good Labaratory Practice and "Chemikaliengesetz" of the Federal Republic of Germany

Principles of method if other than guideline:

The test substance was made into a paste with demineralized water. Three plasters with 0.5 g pasty/plaster (corresponding !59 mg of test
substance per plaster) were stuck on the shorn dorsal skin of the animal. The plasters were removed after 3 minutes, 1 and 4 h, respectively.
Doserange of the test substance was 122-129 mg/kg body weight.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

AG-EE 623 Glutamate

IUPAC Name:

AG-EE 623 Glutamate

Details on test material:

- Name of test material (as cited in study report): AG-EE 623 Glutamate
- Purity test date: 1995-11-29
- Lot/batch No.: WB02

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, 88397 Biberach, Germany
- Age at study initiation: 193-210 days
- Weight at study initiation: 3.7 - 3.9 kg
- Housing: individually in solid wire cages
- Diet (e.g. ad libitum): ad libitum (supplier: Nafag Comp., Gossau/Switzerland)
- Water (e.g. ad libitum): ad libitum (tab water)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3°C
- Humidity (%): 45-75 %
- Air changes (per hr): max. 16 times/h
- Photoperiod (hrs dark / hrs light): 15/9 hours (7 am - 4 pm)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Amount / concentration applied:

ca. 500 mg (corresponding 159 mg test substance/plaster)

Duration of treatment / exposure:

3 min, 1 h, 4 h

Observation period:

1h, 24h, 48h, 72 h and 7 d

Number of animals:

4 albino rabbits, 2 males and 2 females

Details on study design:

TEST SITE
- Area of exposure: dorsal skin of the rabbit
- Type of wrap if used: Fixomull 3*3 cm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal: #1, #2,#3,#4

Time point:

other: 1, 24, 48, 72h and 7d

Score:

0

Max. score:

0

Results 3

Irritation parameter:

other: Necrosis

Basis:

animal: #1, #2, #3, #4

Time point:

other: 1, 24, 48, 72h and 7d

Score:

0

Max. score:

0

Any other information on results incl. tables

The skin changes were evaluated according to the Official Bulletin, "Bundesgesetzblatt", Part I, No. 57, dated December 24, 1981.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Since no skin findings were seen at the administration sites and all animals behaved
unobtrusively, the test substance AGEE 623 Glutamate is considered not to be skin irritating or caustic