Bis(cyclohexyl)ammonium(2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted following the current relevant guideline and fully GLP compliant documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

478-250-9

EC Name:

-

Cas Number:

62965-37-1

Molecular formula:

C26H42N2O4

IUPAC Name:

(2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoic acid; N-cyclohexylcyclohexanamine

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/CA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18.2-21.6 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C +/- 2°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.03.2007 To: 13.03.2007

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

5, 10 and 25% w/v VRT-126017 dcha in acetone:olive oil (4:1 v/v)

No. of animals per dose:

1 animal for the prelimanary study
4 animals for the main study

Details on study design:

In order to find a suitable level for a main study, a preliminary study was conducted. One female was dosed at either 5, 10 or 25% w/v in acetone:olive oil (4:1 v/v). Results indicated that 25% w/v was a suitable high dose level for the main study.
In the main study, groups of four mice were dosed at three dosage levels and a vehicle control. Dosages were selected as follows:
5, 10 and 25% w/v VRT-126017 dcha in acetone:olive oil (4:1 v/v)
In each phase of the study, the mice were treated by daily application of 25 Gl of each of one of these three concentrations, or vehicle control, to the
dorsal surface of both ears for three consecutive days

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Vehicle control: n.a. 5% w/v: 2.0 10 % w/v: 1.7 25 % w/v: 1.8

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Vehicle control: 2022.10 5% w/v: 4099.30 10% w/v: 3387.10 25% w/v: 3584.70

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

VRT-126017 dcha is not regarded as a potential skin sensitizer

Executive summary:

In the main study, groups of four mice were dosed at three dosage levels and a vehicle control. Dosages

were selected as follows: 5, 10 and 25% w/v Z-L-tert.-Leucine DCHA in acetone:olive oil (4:1 v/v).

In this assay the test/control ratios obtained for 5, 10 and 25% w/v were 2.0, 1.7 and 1.8 respectively which

indicates that Z-L-tert.-Leucine DCHA did not show the potential to induce skin sensitization (delayed contact

hypersensitivity).