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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:
other: Commision Directive: 84/449/EEC 1984
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Healthy female New Zealand White rabbits were obtained from Froxfield Farms (UK) Ltd, Froxfield, Hampshire, and on arrival animals were identified with metal ear tags. Animals were allowed an acclimatisation 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 acclimatisation 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 Commission 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 irritation 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 guidelines.

A 0.5 aliquot of the test article was applied over a previously 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 Commission 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

Referenceopen allclose all

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:
other: Bovine corneal opacity and permeability test (BCOP test)
GLP compliance:
yes (incl. certificate)
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

Opacity1

Mean

Permeability1

MeanIn vitroIrritation Score1, 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 colourless liquid with 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 range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy 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 not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy 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.

 

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:
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 post-dose. 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 pre-test.
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

Additional information

Justification for classification or non-classification

Skin irritation:

In a GLP study according to EEC Commission 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.