Potassium trifluorozincate

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF): Japanese Test Guidelines (draft). Test Reports accompanying an application for registration, Unauthorised English translation, July 2000

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium trifluorozincate

EC Number:

237-537-7

EC Name:

Potassium trifluorozincate

Cas Number:

13827-02-6

Molecular formula:

F3Zn.K

IUPAC Name:

potassium trifluorozincuide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Nocoloc Zn Flux
- Physical state: white powder
- Batch 280200
- Analytical purity: > 99%
- Storage condition of test material: at room temperature in the dark
- Expiry date: 27 march 2003 (allocated by NOTOX, 1 year after receipt of the test substance)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: At least 6 weeks
- Weight at study initiation: At least 1.0 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37,5 cm)
- Diet: Standard laboratory rabbit diet (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England) approx. 100 g per day. In addition, hay (BMI, Helmond, the Netherlands) was provided twice a week.
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 21 +/- 3 C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 grams of test substance moistened with 0.2 mL water

Duration of treatment / exposure:

4 hours

Observation period:

72 hour

Number of animals:

3 (male)

Details on study design:

Approximatly 24 hours before treatment, the dorsal fur was clipped, exposing an area of approximatly 150 cm2. Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring. Each animal was treated by dermal application of 0.5 grams of the test substance which was moistened with 0.2 mL of the vehicle and applied to skin of one flank, using a metalline patch of 2x3 cm. The pastch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.

Observations:
- Mortality: Twice daily
- Toxicity: At least once daily
-Body weight: Day of treatment (prior to application) and at termination
- Irritaion: The skin reactions were assessed at approximatly 1, 24, 48 and 72 hours after the removal of the dressing and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1-72 hour

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1-72 hour

Score:

0

Max. score:

4

Irritant / corrosive response data:

- No skin irritation was observed.
- There was no evidence of a corrosive effect on the skin.

Other effects:

- Coloration: No staining of the treated skin by the sest substance was observed.
- Toxixity/ Mortality: No symptoms of systemnic toxicity were observed in the animals during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not irritating to the skin.

Executive summary:

In a GLP-compliant OECD guideline 404 study, rabbits were exposed to Nocoloc Zn Flux to determine skin irritating properties. 0.5 g of the test substance moistened with 0.2 mL water was applied under semi-occlusive conditions to the skin of 3 rabbits for 4 hours. After the removal of the patches animals were observed for 72 hours. No evidence of skin irritation was noted (erythema and edema scores were 0 at all time points (1, 24, 48 and 72 hours) in all animals). Based on the results of the study, the test substance is considered to be not irritating to skin.