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EC number: 701-024-0 | CAS number: 26038-87-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- A read-across approach is applied between Reaction products of monoethanolamine and boric acid (1:1) and Reaction products of monoethanolamine and boric acid (1:3) for the human health endpoints due to the structural similarity of the two reaction products (Scenario 6 in ECHA’s RAAF document), both resulting from the same starting materials (only the ratio is different), and through the same manufacturing process.
Commercial MEA Polyborate products are commonly formulated at either 1:1 or 1:3 mole ratios of MEA to boric acid, or sometimes at ratios in between. All compositions in this range contain equilibrium mixtures of the exact same chemical species, but with somewhat different population distributions.
The existing physico-chemical, toxicological, environmental fate and ecotoxicological data already showed good correlation with no significant differences between the two ratios.
The results of the newly commissioned, additional anchoring studies (water solubility, vapour pressure and octanol-water coefficient, Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assays, acute toxicity studies via dermal route and oral route) showed good correlation between Reaction products of monoethanolamine and boric acid (1:1) and Reaction products of monoethanolamine and boric acid (1:3), and therefore further supported our category hypothesis.
Based on the lack of dermal irritation responses in the rabbit from dermal application of MEA Polyborate 1:3, no GHS classification for skin irritation is proposed for both 1:1 and 1:3 ratios. Three 0.5 ml doses of undiluted MEA Polyborate 1:3 were applied to the dorsum of a single New Zealand White rabbit. Each test site was covered by a gauze patch, which was removed after exposure periods of 3 minutes, one hour and four hours. Dermal reactions were assessed immediately after removal of each dressing. All dermal sites were re-assessed 24, 48 and 72 hours after removal of the last dressing. No dermal irritation was observed at any of the three sites or time periods (Covance 1998b). In addition, in vitro and in vivo eye irritation studies are available on both ratios, and show correlation with only slight difference, i.e. MEA Polyborate 1:1 is not irritating in an in vivo eye irritation study, whilst MEA Polyborate 1:3 is moderately irritating.
On this basis MEA Polyborate 1:1 is considered not to be an irritant to skin.
Category: MEA Polyborates - GLP compliance:
- yes (incl. QA statement)
- 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
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the criteria described in EEC Commission Directive 91/325/EEC of 1st March 1991, MEA Polyborate 1:1 is not classified for skin irritation/corrosion. Based on the justification in the field ' Justification for type of information', this results is applicable for MEA Polyborate 1:3.
- 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, MEA Polyborate 1:1 is not classified for skin irritation/corrosion. Based on the justification in the field ' Justification for type of information', this results is applicable for MEA Polyborate 1:3.
Referenceopen allclose all
Mean scores for erythema and oedema (calculated from the values recorded at the 24,48 and 72 hour readings) were used.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Amount / concentration applied:
- 750 microlitres
- 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
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: not severe irritant or corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- MEA Polyborate 1:3 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 1:3 using the Bovine Corneal Opacity and Permeability test (BCOP test).
This summary describes the ocular irritation properties of MEA Polyborate 1:3 on an isolated bovine cornea. The possible ocular irritancy of MEA Polyborate 1:3 was tested through topical application for 10 ± 1 minutes.
Batch EU-01696 of MEA Polyborate 1:3 was a clear colourless liquid with a purity of 68% 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 1:3 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.0 after 10 minutes of treatment.
Finally, it is concluded that this test is valid and that MEA Polyborate 1:3 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:
- key study
- Study period:
- March - April 1998
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine the irritancy or corrosive effect of the particular chemical by the single installation into the cinjunctival sac of a rabbit to permit the estimation of the hazard it presents to man in the event of inadvertant contamination of the eye.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Charle River Uk Ltd, Margate, U.K.
- Age at study initiation:
- Weight at study initiation: 3.63 kg
- Housing:Individually housed in floor pens
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):16-22 deg. C
- Humidity (%):40-80%
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light):12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Observation period (in vivo):
- 1,4,24,48,72 hours after treatment
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: Not done
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: visual or by biomicroscope - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: not given
- Score:
- ca. 0
- Reversibility:
- fully reversible within: two days
- Remarks on result:
- other: Other data (time point, scoring)not available in the report
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: one animal only
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not documented
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not documented
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Single ocular administrations of MEA Polyborate 1:3 135 g/L resulted in only minor reversible irritation reactions of the conjunctivae. The cornea and iris remained overtly unaffected by installation of the test article.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit.
A single installation of the test material to the left conjunctival sac of one rabbit produced a moderate sting reaction.
Injection of the conjunctival blood vasculature, slight chemosis and a moderate ocular discharge. This conjunctival irritation persisted at examinations undertaken one half hour and one hour after dosing. Resolution of the conjunctival irritation had commenced four hours after dosing and was complete two days after.The cornea and iris remained overtly unaffected by installation of MEA Polyborate 1:3 135 g/L.
Applied fluoroscein was not absorbed into the cornea at either the 24 hour or 48 hour examinations.
Single ocular administrations of MEA Polyborate 1:3 135 g/L resulted in only minor reversible irritation reactions of the conjunctivae. The cornea and iris remained overtly unaffected by installation of the test article.
Referenceopen allclose all
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 |
-0.001 |
0.0 |
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).
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. This result is considered applicable for MEA Polyborate 1:3 based on the justification elaborated in the endpoint study record and in the Category Justification Document.
Eye irritation:
Single ocular administrations of MEA Polyborate 1:3 135 g/L resulted in only minor reversible irritation reactions of the conjunctivae. The cornea and iris remained overtly unaffected by installation of the test article.
MEA Polyborate 1:3 is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.
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