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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 14-40 weeks
- Weight at study initiation: 3.33-4.35 kg
- Fasting period before study: overnight
- Housing: individually
- Diet: 125 g (Rabbit Diet Pellets) per day
- Water: ad libitum
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: treatment site was ‘wetted’ with 0.5ml of reverse osmosis water

Controls:

other: An additional site was similarly treated with the exception of test substance and acted as a control

Amount / concentration applied:

0.5 g of the test substance

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: porous gauze pad secured with ‘blenderm’ surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing: washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1-3

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: 1-3

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No sign of irritation was apparent in any animal at any times during the observation period

Other effects:

There was no sign of toxicity or ill health in any rabbit during the observation period

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The Primary Irritation Index was calculated to be 0.0; VRT-126017 dcha was classified as ‘nonirritant’ according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, “Irritating to skin”, in accordance with Commission Directive 2001/59/EC

Executive summary:

Three rabbits received a single four hour, semi-occlusive, dermal administration of approximately

0.5 g of the test substance as supplied and were observed for 72 hours.

No sign of irritation was apparent in any animal at any times during the observation period.