L-Lysine, N2,N6-bis[N-(1-oxododecyl)glutamyl]-, sodium salt (1:?)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between December 16, 2003 and January 9, 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Pellicer

IUPAC Name:

Pellicer

Details on test material:

Chemical name: Sodium salt as a condensation product of N-lauroyl-L-glutamic acid and L-lysine
Secondary name: LGM
Lot number: 10L-15
Description: white powder

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Sankyo Labo Service Corporation
- Age at study initiation: not stated
- Weight at study initiation: ca 340 g
- Housing: animals were housed in an aluminum cage (W 350 x D 400 x H 200 mm, Natsume Seisakusho Co., Ltd.)
- Diet: animals had free access to pellet food (RC4: Oriental Yeast Co., Ltd.) .
- Water: animals had free access to water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C ± 2°C
- Humidity (%): 50% ± 10%,
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): lighting time: 12 hours from 6:00 to 18:00

IN-LIFE DATES: From: Day 0 To: End of study

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

10%, 3%, 1%, 0.3%, 0.1%, 0.03%, and 0.01% solutions of the test material.

Challenge

Challenge 1

Route:

intradermal and epicutaneous

Vehicle:

water

Challenge 2

Concentration / amount:

10%, 3%, 1%, 0.3%, 0.1%, 0.03%, and 0.01% solutions of the test material.

No. of animals per dose:

A total of 23 animals were included in the test, including 8 in the preliminary test, 10 in sensitization group, and 5 in control group.

Details on study design:

RANGE FINDING TESTS:
Primary irritation by intradermal administration: 10%, 3%, 1%, 0.3%, 0.1%, 0.03%, and 0.01% solutions of the product (solvent: physiological saline) were intradermally administered to the ventral area. P
rimary irritation by closed patch: 30%, 10%, 3%, 1%, 0.3%, and 0.1% solutions of the product (solvent: distilled water for injection) were applied to the ventral area by closed patch for 24 hours.

Sensitization by intradermal administration
A dose of 0.1 ml of each sample (a, b and c) was administered to both sides of the lower back on Day 0.

Sensitization by closed patch
A dose of 0.2 mL placed on the lint cotton (2 × 4 cm) was applied by closed patch using a nonpermeable adhesive plaster for 48 hours on the 7th day of sensitization.

Elicitation
Elicitation was performed by closed patch for 24 hours at 21 days after the initiation of sensitization. A dose of 0.1 mL of each sample impregnated to the cloth part of the test adhesive plaster was applied to the ventral area. The application site of the sample was changed for each animal in order to average sample reactions associated with the site.

Positive control substance(s):

yes

Remarks:

DNCB

Results and discussion

Positive control results:

The technique employed in the test showed a normal response to DNCB, a known sensitizing substance, proving the validity of this experimental technique.

Any other information on results incl. tables

Clinical signs: No abnormalities were found in sensitization and elicitation treatments, and all animals had a steady weight gain.

Skin findings:

Skin reaction was found negative in both sensitization and control groups during the observation.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the above results, no evidence of skin sensitization was found in the product. The validity of the technique employed in the test was proved as it showed a normal response to DNCB, a known sensitizing substance.

Executive summary:

Skin sensitization test of sodium salt as a condensation product of N-lauroyl-L-glutamic acid and L-lysine in guinea pigs was investigated by the method based on the guinea pig maximization test. Eight animals were included in the preliminary test, 10 in sensitization group, and 5 in control group. The lower back of guinea pigs was sensitized by intradermal administration of the following three solutions: (a) an emulsion in an equal amount of Freund's complete adjuvant and physiological saline, (b) 0.3% solution of the product (solvent: physiological saline), and (c) the mixed liquor of equal amount of 0.6% solution of the product (solvent: physiological saline) and Freund's complete adjuvant. In addition, 5% solution of the product (solvent: distilled water for injection) was applied by closed patch to the intradermal administration site for 48 hours on the 7th day of sensitization. As elicitation, 1%, 0.3%, and 0.1% solutions of the product (solvent: distilled water for injection) were applied by closed patch for 24 hours on the 21st day of sensitization.

Based on the results of the study, no evidence of skin sensitization was found in the product. The validity of the technique employed in the test was proved as it showed a normal response to DNCB, a known sensitizing substance.