Naphthenic acids, zinc salts, basic

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-12-20 to 2006-01-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002-04-24

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

dated 2005-12-13

Test material

Test material information

Constituent 1

Reference substance name:

Naphthenic acids, zinc salts

EC Number:

234-409-2

EC Name:

Naphthenic acids, zinc salts

Cas Number:

12001-85-3

IUPAC Name:

zinc bis[3-(3-ethylcyclopentyl)propanoate]

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quaratier Labaste - F40260 Linxe)
- Weight at study initiation: 2.35 kg - 2.73 kg
- Housing: each animal was kept in an individual box (dimensions: 61 cm X 46 cm X 34 cm) installed in conventional air conditioned animal husbanding.
- Diet (ad libitum): UAR 112 from UAR in 91360 Villemoisson s/Orge, France
- Water (ad libitum): tap-water from public distribution system
- Acclimation period: a minimal 5-day acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature: between 18°C and 22°C
- Relative humidity: between 30% and 53%
- Air recycling: at least 10 cycles per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the test item was applied, as supplied, at a dose of 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1 hour and then 24, 48 and 72 hours as well as 4 to 14 days after removal of the patch

Number of animals:

3 male rabbits

Details on study design:

Initially, a single animal was treated. After consideration of cutaneous responses produced in the first treated animal, two additional animals were treated.
TEST SITE
- Area of exposure: approximately 24 hours before the test, the rabbits' backs and flanks are shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm^2. Any animal with skin lesions is replaced.
The test product is applied to a small area (approx. 6 cm^2) of shorn skin (unaffected zone) and covered with a gauze patch, which is maintained in position by a semi-occlusive dressing. The dressing is covered with an elastic strap taped in place around the animal's body, taking care not to impede its respiratory and abdominal movements.

SCORING SYSTEM: according to Draize scale

OBSERVATIONS:
The systemic toxicity, expressing by behavioural abnormalities, alteration of neuro-vegetative reactions or decrease feeding, and any toxic effects are to be logged and described.
The animals are weighed at the start and at the end of the test.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Slight dryness from D2 to D14

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Slight dryness from D3 to D9

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after the test item application, very slight (barely perceptible) erythema was noted.
Twenty four hours after the test item application, it was noted, on the treated area, a very slight to well-definite erythema in the 3 animals. Moreover, it was noted a slight dryness on the cutaneous treated area, from the 2nd or 3rd day of the test in two animals. This reaction was ever noted at the end of the observation time (D14) in one animal.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

The test substance is not irritating to the skin.
According to the EC-Regulation 1272/2008 and its subsequent amendments, the test item is not classified as skin irritant.