Potassium fluoroborates and potassium fluorohydroxyborates, exothermic reaction products of boron and potassium hydroxides and fluorohydroxides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-02-21 to 1983-03-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study reliable with restrictions - the purity and the stability of the test substance was not stated in the study report. In this study the test substance was not only tested on intact skin, but also in abraded skin. The results of the intact skin were reported in this endpoint study record. The results of the abraded skin were reported in the following endpoint study record: Section 7.3.1 Skin irritation / corrosion: s_Zechel_1983

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981-05-12

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Flußmittel Degussa h-Paste

IUPAC Name:

Flußmittel Degussa h-Paste

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

- Name of test material (as cited in study report): Flußmittel Degussa h-Paste
- Physical state: white paste
- Density: 1.4 g/mL
- pH value: 8

Specific details on test material used for the study:

The substance was initially pre-registered as EC 286-925-2 and this was the information reported in the analytical reports. Only after REACH SID refinements, the substance was correctly identified as an UVCB and required a refined EC entry. For this reason, the existing EC 286-925-2&name identifiers are reported in the testing material & in the testing robust study summaries

Test animals

Species:

rabbit

Strain:

other: White Russian (Albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG
- Age at study initiation: approx. 8-10 months
- Weight at study initiation: 2.1-2.2 kg
- Housing: caging: stainless steel cages type Asta; number of animals per cage: 1
- Diet: Standard test animal diet Altromin®
- Water (ad libitum): water
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C±1°C
- Relative humidity: 50-60%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shorn skin

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/patch

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the bandage (maximum 14 days)

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure / Type of wrap if used: the test substance was given on a wad of cotton, in order to ensure application without loss on the shorn dorsal skin area between shoulder and sacrum. The site of application was covered with an approximate 6.25 cm^2 linen cloth which adhered to a synthetic adhesive film. A bandage wrapped around the trunk (Acrylastic, supplied by P. Beiersdorf adn Co. AG, Hamburg, No. 2408, width 8 cm) provided occlusion. The dorsal skin area of each rabbit was subdivided into two areas on each side of the vertebral column (a total of 4). The contralateral areas differed from one another in that they consisted on the left side of uninjured (intact) skin and on the right side of artificially injured (sacrified) skin. Scarification took place solely superficially avoiding deeper defects and bleeding. Each of the 4 areas was covered with a patch of appropriate size; 2 patches served for covering the applied test product (one each on intact and sacrified region), 2 covered untreated skin regions at corresponding places.

SCORING SYSTEM: according to the Draize scale
Systemic toxic effects occurring were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Very slight oedema was observed at the 1 hour observation.

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Very slight oedema was observed at the 1 hour observation.

Irritant / corrosive response data:

NOTE: The results of the intact skin were only stated in this result section. The results of the abraded skin were stated in the endpoint study record Section 7.3.1 Skin irritation / corrosion: s_Zechel_1983 (abraded skin).

The single application of 0.5 g Flußmittel Degussa h-Paste to the intact dorsal skin of the rabbit provoked erythemas and oedemas in 2 animals. In 1 animal neither erythema nor oedema was observed.
Erythemas occurred only 24 hours after the end of exposure and were assessed with gradings of 1 and 2 (very slight to well defined erythemas).
Oedemas, however, were immediately observed. They were seen at a maximum until day 2 of observation and obtained a grading of 1 (very slight oedemas).
Skin regions treated with solvent/suspension medium without test substance (control): without finding.

Other effects:

Systemic toxic effects did not occur after dermal application of the test product. The general condition of the test animals was undisturbed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not a skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.