L-proline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1993-11-01 to 1994-01-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, used for read-across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Updated July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Updated Dec 1992, OJEC L383A

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 002

Constituent 2

Reference substance name:

1-(2-amino-3-methylbutyryl)pyrrolidine-2-carboxylic acid

EC Number:

416-950-8

EC Name:

1-(2-amino-3-methylbutyryl)pyrrolidine-2-carboxylic acid

Cas Number:

20488-27-1

Molecular formula:

C10H18N2O3

IUPAC Name:

1-(2-amino-3-methylbutyryl)-pyrrolid ine-2-carboxylic acid

Test animals

Species:

rat

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent
- Age at study initiation: no data
- Weight at study initiation: 3981 - 4458 g
- Housing: Individually in aluminium sheet cages (65.2 cm x 68.9 cm x 45.7 cm). The floor of the cage was made of perforated alumium sheet and the door was made of stainless steel rods.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 6 days

ENVIRONMENTAL CONDITIONS
according to guideline

IN-LIFE DATES: From: To: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

Test sample (ca. 500 mg) was moistened with 0.3 - 0.4 ml of deionised water.

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 500 mg


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 - 0.4 ml
- Purity: deionized water

Duration of treatment / exposure:

Dressings were left in position for at least 4 h.

Observation period:

3 d.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 2.5 x 2.5 cm
- % coverage: entire area of exposure
- Type of wrap if used: Treated area secured with 2 crossed strips of surgical tape (ca. 1 x 8 cm). This was covered by a piece of impermeable rubber sheeting (ca. 35 x 13 cm), wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape ( 7.5 cm wide).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Clean swabs of absorbent cotton wool soaked in clean warm water. Then dried gently with clean tissue paper.
- Time after start of exposure: At least 4 h

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 30 - 60 min

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 1 day

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 2 days

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 3 days

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 30 - 60 min

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 1 day

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 2 days

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

All individual animals showed score "0".

Time point:

other: 3 days

Score:

0

Max. score:

4

Other effects:

No other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

L-valyl-L-proline was tested for skin irritation / skin corrosion properties. The substance was non-irritant to rabbit skin following a single four-hour application.