vinasses, residue of fermentation, depotassified

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:

key study

Study period:

09 Aug - 19 Aug 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

In this study, the substance tested, Vinasses, residue of fermentation, has a chemical composition analogue to Vinasses, residue of fermentation, depotassified and therefore is used in an analogue approach. The analogue approach justification is described in theendpoint study summary. GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Vinasses, residue of fermentation

IUPAC Name:

Vinasses, residue of fermentation

Constituent 2

Reference substance name:

932-215-3

IUPAC Name:

932-215-3

Details on test material:

- Name of test material (as cited in study report): NATU-C
- Physical state / appearance: cloudy yellow-brown liquid with white particles (determined at NOTOX)
- Analytical purity: 100%
- pH: 3-4
- Lot/batch No.: 13-07-2005
- Expiration date of the lot/batch: 13 September 2005
- Storage condition of test material: in refrigerator (2-8°C) in the dark
- Stability under storage conditions: stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kissleg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: controlled environment, individually in labelled cages with perflorated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany), approx. 100 g per day. Hay (BMI, Helmond, the netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0 (actual range: 20.5-21.6)
- Humidity (%): 30-70 (actual range: 44-78)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity.

IN-LIFE DATES: 09 Aug - 19 Aug 2005

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacant areas of untreated skin of each animal were served as controls

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

3 min, 1 and 4 h (1 animal)
4 h ( 2 further animals)

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2x3 cm, flank
- Type of wrap if used: metalline patch was mounted on micropore tape , which was wrapped with Coban elastic bandage (Lohmann GmbH, Neuwied, Germany (Metalline) and 3M, St. Paul, Minnesota, USA (Micropore and Coban)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of a dressing, the treated skin was cleaned of residual test substance using water
- Time after start of exposure: 3 min, 1hour and 4 hours (one rabbit); 4 hours (two further rabbits)

SCORING SYSTEM: Erythema and eschar formation:
no erythema: 0; very slight erythema: 1; well-defined erythema: 2; moderate to severe erythema: 3; severe erythema: 4
Oedema formation:
no oedema: 0; very slight oedema: 1; slight oedema: 2; moderate (raised approx. 1 mm) oedema: 3; severe oedema:4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of 3 animals

Time point:

other: mean over 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of 3 animals

Time point:

other: mean over 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Four-hour exposure to 0.5 mL of NATU-C resulted in very slight erythema in the treated skin areas of the three rabbits. The skin irritation had resolved within 24 hours after exposure in all animals. No oedema was observed.
There was no evidence of a corrosive effect on the skin.

Other effects:

No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Base on these results NATU-C is considered to be non-irritating.

Body weights

animal 730, 10 -12 weeks old: prior to application 2274 g; at termination 2399g

animal 739, 7 -9 weeks old: prior to application 1745 g; at termination 1911 g

animal 742, 7 -9 weeks old: prior to application 1757 g; at termination 1639 g

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU