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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-03-01 to 1983-03-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions - the purity and stability of the test item were missing in the study report Deficiency from the guideline: - Draize scale: cornea and iris were not included in the scoring of conjunctival redness

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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1981-05-12

Deviations:

yes

Remarks:

please refer to "Rationale for reliability incl. deficiencies" above

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 / tissue source

Species:

rabbit

Strain:

other: White Russian (Albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 4-7 months
- Weight at study initiation: 2.0-2.6 kg
- Fasting period before study: diet withdrawal on the day of treatment
- 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

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test product was applied Into the conjunctival sac of one eye of the correspondingly fixed rabbit, after previously carefully pulling the lower lid away from the eyeball. Thereafter the lids were gently held together for about 1 second in order to prevent loss of Instilled test substance. The other eye of each animal remained untreated and acted as control.

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

1, 24, 48, and 72 hours after the instillation of the test substance (maximum 21 days)

Number of animals or in vitro replicates:

3 female rabbits

Details on study design:

Only test animals without any signs of eye diseases were used in the study.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes were not rinsed with aqua font, after application of the test substance.

SCORING SYSTEM: according to the Draize scale
Apart from the assessment of the primary irritation of the test product, additional findings, which did not affect the eye, were recorded (systemic toxic effects).

TOOL USED TO ASSESS SCORE: the eyes were examined with a hand-slit-lamp (model Ophthalmoskop, supplied by Heine, type med. 261).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: Scattered/diffuse area of opacity (grade 1) was observed at the 1 h observation. The area of cornea involved was > one quarter, but less than half during the 1, 24, and 48 h observations. During the 72 h observation one quarter or less but not zero.

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Diffuse redness, crimson colour, individual vessels not easily discernible (grade 2) was observed at the 1 h observation. Discharge with moistening of the adjacent lids and hairs (grade 2) was observed at the 1 h observation.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Obvious swelling with partial eversion of lids (grade 2) was observed at the 1 h observation.

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Diffuse redness, crimson colour, individual vessels not easily discernible (grade 2) was observed at the 1 h observation. Discharge with moistening of the adjacent lids and hairs (grade 2) was observed at the 1 h observation.

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Obvious swelling with partial eversion of lids (grade 2) was observed at the 1 h observation.

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Diffuse redness, crimson colour, individual vessels not easily discernible (grade 2) was observed at the 1 h observation. Discharge with moistening of the adjacent lids and hairs (grade 2) was observed at the 1 h observation.

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Obvious swelling with partial eversion of lids (grade 2) was observed at the 1 h observation.

Irritant / corrosive response data:

The single instillation of 0.1 g Flußmittel Degussa h-Paste into the conjunctival sac of the rabbit eye caused slight changes in cornea and conjunctiva.
In the cornea signs of irritation with the grading 1 (scattered or diffuse opacity) occurred in 1 of 3 test animals already 1 hour after exposure of the test product. Firstly less than half of the corneal area and subsequently approximately one quarter of the corneal area were involved. This finding persisted up to day 14 of the observation period.
In the Iris no changes occurred due to the contact with the test product.
The conjunctiva reacted with redness, swelling, and discharge. These findings occurred in all 3 animals already after 1 hour of exposure of the test product. Redness was diffuse with the grading 2. Obvious swelling with partial eversion of lids (grade 2) occurred. The observed discharge led to moistening of adjacent lids and hairs. The changes were detectable up to 48 hours at the longest after exposure of the test product into the conjunctival sac.

Other effects:

Systemic toxic effects did not occur after conjunctival application of the test substance. 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 material is non-irritating to the eyes.
According to 67/548/EC and subsequent regulations, the substance is not classified as an eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is not classified as an eye irritant.