Reaction products of monoethanolamine and boric acid (1:1)

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

72 hours

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

other: commision directive: 84/449/EEC 1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Healthy female New Zealand White rabbits were obtainedfrom Froxfield Farms (UK) Ltd, Froxfield, Hampshire, and on arrival animals were identified with metal ear tags. Animals were allowed an acclimitisation period of at least five days.
The rabbits were individually housed in grid bottomed metal cages. An antibiotic-free rabbit diet (SQC Standard rabbit pellets produced by Special Diets Services, With am, Essex) and mains drinking water via an automatic watering system were freely available. Certificates of analysis for both diet and drinking water are held on file at Toxicol laboratories.

The rabbit holding room was air conditioned with temperature in the range 17-20 deg. C and relative humidity in the range 37-51% during the acclimitisation and study periods.

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 female

Details on study design:

One hour after the removal of the patches and test article, the treated sites were assessed for signs of reaction to treatment. Similar examinations were made 24, 48 and 72 hours after patch removal.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Irritant / corrosive response data:

1 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 1 0 None
24 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 1 0 None
48 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 0 0 None
72 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 0 0 None

Other effects:

none

Mean scores for erythema and oedema (calculated from the values recorded at the 24,48 and 72 hour readings) were used.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a GLP study according to EEC Commision Directive 91/325/EEC of 1st March 1991, MEA Polyborate 1:1 is not irritating to New Zealand White rabbits.

Executive summary:

The purpose of this study was to assess the degree of irrititaion produced by the test article when applied to the skin of the albino rabbit. The procedures e used were in accordance with EEC Annex V guidlines.

A 0.5 aliquot of the test article was applied over a previouslly clipped area of about 6 sq cm of the dorsal skin of each of 3 albino rabbits. The test article was held in contact with the skin, under a semi-occlusive patch assembly, for a 4 hour period. The patches were then removed and skin reaction assessed after one, 24, 48 and 72 hours.

The treated site on 2 of the 3 rabbits remained free from apparent irritation throughout the 72 hour observation period. A barely perceptable erythema was noted at the treated site on the third animal one and 24 hours after patch removal but was no longer apparent at the 48 and 72 hour examinations.

The test article did not produce significant irritation in any animal.

According to the criteria described in EEC Commision Directive 91/325/EEC of 1st March 1991, the test article would not require labelling with either of the risk phrases "R34 Causes burns" or "R38 Irritating to skin" under the conditions of this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

other: Bovine corneal opacity and permeability test (BCOP test)

GLP compliance:

yes (incl. QA statement)

Species:

other: bovine

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

10 minutes

Observation period (in vivo):

10 minutes

Number of animals or in vitro replicates:

not applicable

Irritation parameter:

cornea opacity score

Remarks:

mean

Value:

0

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

in vitro irritation score

Remarks:

mean

Value:

0.8

Negative controls validity:

valid

Positive controls validity:

valid

Table1            Summary of opacity, permeability andin vitroscores

 

Treatment	Mean Opacity^1	Mean Permeability^1	MeanIn vitroIrritation Score^1, 2
Negative control	0	0.000	0
Positive control (Benzalkonium Chloride)	82	4.144	144
MEA Polyborate 1:1	0	0.050	0.8

 

1     Calculated using the negative control mean opacity and mean permeability values.

2     In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD₄₉₀value).

 

Interpretation of results:

other: not severe irritant or corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

MEA Polyborate 1:1 is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.

Executive summary:

Screening for the eye irritancy potential of MEA Polyborate 1:1 using the Bovine Corneal Opacity and Permeability test (BCOP test).

 

This summary describes the ocular irritation properties of MEA Polyborate 1:1 on an isolated bovine cornea. The possible ocular irritancy of MEA Polyborate 1:1 was tested through topical application for 10 ± 1 minutes.

 

Batch EU-01695 of MEA Polyborate 1:1 was a clear colourlessliquidwith a purity of 40% salt in water. The test substance was applied as it is (750 µl) directly on top of the corneas.

 

The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical rangeindicating that the negative control did not induce irritancy on the corneas.The meanin vitroirritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 144 and was within the historical positive control data range.It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

 

MEA Polyborate 1:1 did notinduce ocular irritation through both endpoints, resulting in a meanin vitroirritancy score of 0.8 after 10 minutes of treatment.

 

Finally, it is concluded that this test is valid and that MEA Polyborate 1:1 is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.

 

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

January 2001

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

not specified

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No data
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA
- Age at study initiation: No data
- Weight at study initiation: 2.5 to 3.1 kg
- Housing: one per cage in suspended cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
No data

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye of each animal served as the control.

Amount / concentration applied:

Test article was used as received.

Duration of treatment / exposure:

The test article (0.1 ml) was placed by syringe into the conjunctival sac which was formed by gently pulling
the lower eyelid away from the eye. After instillation, the lids were held together for approximately one
second to insure adequate distribution of the test article. One eye of each rabbit was dosed. The
contralateral eye served as a control.

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48
and 72 hours postdose. Sodium fluorescein dye procedures were used at the 24 hour observation
interval. These examinations were performed using a Mini-Maglit& flashlight equipped with a high
intensity bulb. Ocular reactions were graded according to the numerical Draize technique.
Body weights were recorded pretest.
The general health of the animals was monitored at each observation time.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 hour

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

Redness, discharge

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1 hour

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

Redness, discharge

Basis:

animal #2

Time point:

other: 24, 28, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

other: 1, 24 hours

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

other: 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in
3/3 eys, cleared by 48 hours.

Other effects:

There were no abnormal physical signs noted during the observation period.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

MEA Polyborate 1:1 is not irritating in a GLP study conducted according to EPA OPPTS 870.2400 (corneal opacity cleared within 48 hours).

Executive summary:

Summary: There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared by 48 hours. There were no abnormal physical signs noted during the observation period.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation:

In a GLP study according to EEC Commision Directive 91/325/EEC of 1st March 1991, MEA Polyborate 1:1 is not irritating to New Zealand White rabbits. Therefore the substance is not classified for skin irritation or corrosion under GHS.

Eye irritation:

MEA Polyborate 1:1 is not irritating in a GLP study conducted according to EPA OPPTS 870.2400 (corneal opacity cleared within 48 hours).

MEA Polyborate 1:1 is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report. Therefore the substance is not classified for eye irritation or corrosion under GHS.