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EC number: 234-521-1 | CAS number: 12007-89-5
- 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
In vivo irritation studies on skin (Weiner et al, 1982), eye and respiratory tract were performed with read-across substance boric acid.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR 163)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan F Plummer
- Weight at study initiation: 1623 - 2922 g - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: Moistened with physiological saline. - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 10
- Details on study design:
- TEST SITE
- Area of exposure: Saddle area
- Type of wrap if used: Occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: Moistened towel
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- animal 1 - 6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- animal 1 - 6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- No irritancy was observed
- Other effects:
- No data
- Interpretation of results:
- other: Not classifiable in the EU
- Remarks:
- Classified in US Toxicity Category IV (slight or no irritation)
- Conclusions:
- The study was performed according to FIFRA (40 CFR 163). No irritancy was observed and it is therefore not classifiable in the EU.
Classified in US in Toxicity Category IV (slight or no irritation).
Data from other studies confirm the results. Further testing not warranted in the interests of animal welfare. - Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meest generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: 172.4 Title 49 Code of Federal Regs (Fed Reg Feb12, 1973)
- Deviations:
- no
- Remarks:
- Although the study was not carried out to OECD protocols, it was carried out to US Government Guidelines and other tests confirm the results. Further testing is therefore not justified in the interests of animal welfare.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- No data
- Number of animals:
- 6
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: Not applicable, no irritation observed.
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Not irritating
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: 173.240 under title 49 of the Code of Federal Regulations, 1973
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- Four h
- Observation period:
- 48 h
- Number of animals:
- Six
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: Not applicable
- Other effects:
- No corrosive effects were noted at any time during the study in any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The corrosive potential of anhydrous boric acid - 100 mesh was evaluated in accordance with the procedure described in section 173.240 (CFR 49). No corrosive effects were noted at any time during the study.
Based on the results the test material was not classified as corrosive. - Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: US Reg. (21 CFR 191.11)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Six rabbits with intact and 6 rabbits with abraded skin. 5 mL of boric acid was applied as a 10 % solution on a cellulose pad.
- Concentration: 10 % solution - Duration of treatment / exposure:
- No data
- Observation period:
- No data
- Number of animals:
- 12
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- other: Intact plus abraded skin
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No data
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- guinea pig
- Strain:
- Hartley
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Six guinea pigs with clipped depilated intact abdomens and 6 guinea pigs with clipped depilated, abraded backs. 5 mL of boric acid was applied as a 10% solution on a cellulose pad.
- Concentration: 10 % - Duration of treatment / exposure:
- No data
- Observation period:
- No data
- Number of animals:
- 12
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.1
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- other: Intact plus abraded skin
- Irritant / corrosive response data:
- Not irritating
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating
Referenceopen allclose all
Results for skin irritation:
Site |
Time |
Erythema |
Edema |
Intact |
24 h |
0 |
0 |
72 h |
0.25 |
0 |
|
Abraded |
24 h |
0 |
0 |
72 h |
0.17 |
0 |
|
Average score |
24 h, 72 h |
0.105 |
0 |
Primary irritation and corrosivity scores in rabbits following 4-h patch application of anhydrous boric acid - 100 mesh.
Rabbit No. |
Skin |
Erythema-Eschar Observation |
Edema Observation |
||||
4 h |
24 h |
48 h |
4 h |
24 h |
48 h |
||
7 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
1 |
1 |
0 |
0 |
0 |
|
8 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
9 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
11 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
|
12 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
Scoring key:
Evaluation of skin reaction |
Value |
Erythema and eschar formation |
|
No erythema |
0 |
Very slight erythema (barely perceptible) |
1 |
Well-defined erythema |
2 |
Moderate to severe erythema |
3 |
Severe erythema (beet redness) to slight eschar formation (injuries in depth) |
4 |
Edema formation |
|
No edema |
0 |
Very slight edema(barely perceptible) |
1 |
Slight edema (edges of area well defined by definite raising) |
2 |
Moderate edema (raised approximately1 mm) |
3 |
Severe edema (raised more than 1 mm and extending beyond the area of exposure) |
4 |
191.11 of Regulations under the Federal Hazardous Substances Labelling Act.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR 158, 162); TSCA (40 CFR 798). Although not carried out to an OECD protocol, the study has been carried out to a US EPA acceptable protocol and conducted in accordance with GLP standards (40CFR160).
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Approved USDA supplier - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg boric acid was applied to one eye of each of 6 rabbits.
- Concentration: Boric acid used at up to 5 % in eye washes - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Rinsed with physiological saline
- Time after start of exposure: 24 h
SCORING SYSTEM: According to Draize, reported as according to EU 67/548/EEC - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 13.6
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Average 60 min score was 0.17
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slightly irritating
Changes in colouration and texture of the eye and blistered appearance to conjunctiva.
Chemosis and redness reversed by seven days. - Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Toxicity Category III - corneal involvement or irritation clearing in 7 days or less.
- Conclusions:
- The study was performed according to FIFRA (40 CFR 158, 162); TSCA (40 CFR 7998). Minor effects on the iris and effects on the conjunctivae were reversed by Day 7.
Classified in US category III (40 CFR 156) "corneal involvement or irritation clearing in 7 days or less".
Non irritant under US CPS (16 CFR 15000.42). - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No data
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rat
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- No data
- Number of animals or in vitro replicates:
- 12
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: One group had eyes irrigated immediately, the other group had no irrigation. - Irritation parameter:
- other: No data
- Basis:
- mean
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The non-irrigated group had mild or moderate erythema in 5/6 animals which subsided by 4th day after treatment. The irrigated group had mild erythema 6/6 and mild oedema 1/6 which subsided by 4th day after treament.
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The non-irrigated group had mild or moderate erythema in 5/6 animals which subsided by 4th day after treatment. The irrigated group had mild erythema 6/6 and mild oedema 1/6 which subsided by 4th day after treament.
Classified as Not irritating. - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA 40 CFR 158
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Irish Farms (Norco, CA)
- Weight at study initiation: 2.07 and 2.47 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remained untreated to serve as a control.
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 72 h in unrinsed rabbits
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- Nine in total; 6 in Group A (unrinsed) and 3 in Group B (rinsing).
- Details on study design:
- One drop of proparacaine was applied to both eyes. Approximately 0.1 g of the test article was instilled into the lower conjunctival sac of the right eye of each test animal. The lids were held together for one second and released.
The three animals in Group B had the test article rinsed from the eye with normal saline immediately following instillation. The eyes were examined at 24, 48 and 72 h after instillation and the presence of irritation was recorded. - Irritation parameter:
- other: No data
- Basis:
- other: No data
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- The test article was irritating when applied to the eyes of rabbits. The severity of the irritation was less irritating in those animals that were rinsed with saline immediately following test article application. The irritation was confined to redness and slight swelling of the conjunctival tissue. This irritation decreased over time with a return to normal in two of the three rabbits 72 h after exposure to the test article.
The rabbit that did not have the test article immediately rinsed from the eyes had a more severe reaction to the test article. In addition to the redness and swelling, there was slight corneal swelling and one animal developed iritis at 24 h. The eyes were improved in two animals at 48 h and in four animals at 72 h. The irritation in the remaining 2 group A animals was slight and not considered significant. Therefore the test was terminated at 72 h. - Other effects:
- No data
- Interpretation of results:
- other: Toxicity Category IV
- Remarks:
- Criteria used for interpretation of results: 40 CFR 156
- Conclusions:
- The test article was an ocular irritant when applied directly to the eyes of rabbits. It is less irritating when flushed immediately from eyes. The irritation was reversible after 24 h with a return to near normal by 72 h after exposure to the test article. These results place the material in Toxicity category IV (40 CFR 156) by ocular administration.
Referenceopen allclose all
Results of the eye irritation study:
Score (average of animals investigated) |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
|||
0 to 4 |
0 to 2 |
0 to 3 |
0 to 4 |
|
60 min |
0.17 |
0.83 |
1.00 |
1.67 |
24 h |
0.00 |
0.33 |
1.00 |
0.83 |
48 h |
0.00 |
0.00 |
1.00 |
0.50 |
72 h |
0.00 |
0.00 |
0.83 |
0.33 |
Average 24 h, 48 h, 72 h |
0.00 |
0.11 |
0.94 |
0.56 |
Reversibility* |
|
c |
c |
c |
Average time for reversion |
|
By 48 h |
By 7 d |
By 7 d |
*complete
Ocular irritation scores
Group |
Rabbit No. |
Eye |
0 h |
24 h |
48 h |
72 h |
A |
289 |
Right |
0 |
IIIA2, IIIBI |
0 |
0 |
Left |
0 |
0 |
0 |
0 |
||
290 |
Right |
0 |
I1, II1, IIIA2, IIIB2 |
IIIA1 |
IIIA1, IIIB1 |
|
Left |
0 |
0 |
0 |
0 |
||
294 |
Right |
0 |
IIIA1, IIIB1 |
0 |
0 |
|
Left |
0 |
0 |
0 |
0 |
||
295 |
Right |
0 |
IIIA2, IIIB2 |
0 |
0 |
|
Left |
0 |
0 |
0 |
0 |
||
296 |
Right |
0 |
I1, IIIA1, IIIB2 |
IIIA1, IIIB1 |
IIIA1, IIIB2 |
|
Left |
0 |
0 |
0 |
0 |
||
297 |
Right |
0 |
IIIA1, IIIB1 |
IIIA1, IIIB1 |
0 |
|
Left |
0 |
0 |
0 |
0 |
||
B |
291 |
Right |
0 |
IIIA2, IIIB1 |
IIIA1, IIIB2 |
IIIA1, IIIB1 |
Left |
0 |
0 |
0 |
0 |
||
292 |
Right |
0 |
IIIA1, IIIB1 |
IIIB1 |
0 |
|
Left |
0 |
0 |
0 |
0 |
||
293 |
Right |
0 |
IIIA1, IIIB2 |
IIIA1 |
0 |
|
Left |
0 |
0 |
0 |
0 |
I = cornea
II = iris
II = conjunctivae
A = redness
B = swelling
0 = normal
1 = slight
2 = moderate
3 = severe
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation
Boric acid is not a skin irritant.
Eye Irritation
Boric acid induced mild conjunctivae redness and chemosis and minor effects on the iris. The effects were reversible within 7 days. Therefore, no classification is indicated.
Respiratory tract
Borates act as mild sensory irritants, indicated by the effects observed in humans (i.e.nose, eye and throat irritation; sneezing)and by the results of the Alarie-tests by Krystofiak & Schaper (1996) and Kirkpatrick (2010), which demonstrated a depression of the respiratory frequency in mice after exposure to sodium borate. This reflex can be triggered by agents that stimulate receptors in the respiratory tract e.g. on the trigeminal nerve (Wegman et al. 1991, Nielsen et al., 2007, Krystofiak & Schaper, 1996, Kirkpatrick, 2010). The actual mechanism, however, has not yet been elucidated. The Kirkpatrick(2010)study of boric acid using the Alarie ASTM mouse RD50 test was unable to reach an exposure concentration of boric that would cause a 50 % depression of respiration and thus did not meet the criteria specified by the test protocol for a respiratory irritant.
Wegman et al. (1991) and Woskie et al. (1998) proposed changes of osmolarity in the lining fluid of the mucous membrane as possible cause for receptor activation. Changes in osmolarity could also act indirectly by stimulating mast cells to secrete histamine or other immune modulators. Histamine is known to be able to mediate the sensory component of irritation. The importance of osmolarity in the case of borate dusts is further substantiated by Cain et al. (2008) where the changes of local osmolality from a desiccating dust may cause sensations of dryness. They also indicated that more acidic dusts, as compared to borate dusts, would lead to a change in nasal pH which might trigger the nasal receptors in a different way.
Acute irritant effects are extensively documented in human workers exposed to sodium borates (EPA, 2004; Wegman et al. 1991; Garabrant 1984, 1985; Woskie et al., 1994, 1998; Cain et al., 2004, 2008). The described symptoms are typical for those which would be produced in the exposed population rather than being an isolated reaction or response triggered only in individuals with hypersensitive airways. Symptoms include nasal and eye irritation, throat irritations, cough, and breathlessness. Boric acid exposure was only studied by Garabrant (1984) and Cain et al. (2008). The Garabrant (1984) study did not distiquish which of the two exposures (boron oxide or boric acid) was associated with reported symptoms. Boron oxide reacts exothermically with water to form boric acid suggesting a possible mechanism for boron oxide irritancy. It is believed that these irritant effects are caused by the exothermic hydration of boron oxide to boric acid. Cain et al. (2008) reported a NOAEL for irritation among human volunteers inhaling boric acid of 1.75 mg B/m3 (10 mg/m3 of boric acid), the highest exposure evaluated for boric acid. The exposures of 2, 5 and 10 mg/m3 evaluated in Cain et al. (2008) did not reach a level defined by the investigators as being irritating. Furthermore, for any given point in exposure time the dose-response curve had a very low slope, not characteristic of an irritant.
In the Transitional Annex XV Dossier, Poisson regression analysis of the results from Wegman et al. (1991) was used to estimate a NOEC (See Appendix A). For NOEC derivation 15-minute interval exposure data were plotted against the sum of “any symptom” (nose, eye, and throat irritation, sneezing breathlessness, coughing; Table 37, attached in appendix A; Wegman et al., 1991). The lower limits of the exposure ranges presented in Table 37 were used for the non-linear regression analysis (Poisson-model). Applying the equation derived from the regression analysis, resulted in a predicted rate for effects at background of 0.002, with lower and upper 95 % CI of 0.0002 and 0.016, respectively. The upper 95 % CI of this rate was considered equivalent to “no-observed-effect”. The boron concentration with a lower 95 % CI of the predicted rate of symptoms equal to this value (0.016) was used as the point of departure for DNEL derivation. The corresponding boron concentration equals 0.4 mg B/m³. A correction factor of 2 was then applied for the methodological underestimation of exposure measurements resulting in a NOEC of 0.8 mg B/m³. However, Wegman et al. did not study boric acid but instead an alkaline dust containing unspecified sodium borates. And sodium borate information can not be extrapolated to boric acid for irritant responses.
The Wegman data is based on subjective responses on a severity scale assigned to exposure ranges rather than a specific exposure level and contains no clear dose-response information. There is no way to identify where in this exposure spectrum symptoms occurred. Furthermore, symptoms were also reported in the group of workers not considered to be exposed (office workers), making any estimate of the NOEC unreliable.
Benchmark dose analysis was conducted of the data presented in Table 37 of Wegman et al. (1991, attached in Appendix A). Table 37 presents the incidence of “Any Symptom” reported by a participant in the study that was confirmed by both the marker being pressed on the data logger worn by the worker and by a subsequent questionnaire administered by a study technician. The exposure doses used were the calculated mean concentration of each concentration range presented in the table. The identified dose-descriptor for acute irritant effects is the BMDL05 value of 0.94 mg B/m³ based on Wegman et al. (1991). The methods used for exposure measurements in this study were underestimates and a conversion factor of 2.5 was used to correct for the methodological underestimation of exposure measurements. This results in a final BMDL05of 2.35 mg B/m3 for exposure to sodium borate dusts.
An airway sensory irritation respiratory depression (RD50) study of boric acid and sodium tetraborate pentahydrate was conducted in male Swiss-Webster mice based on the ASTM E981-04 (2004) standard test method of estimating sensory irritancy of airborne chemicals. The ASTM E981-04 sensory iritancy test (Alarie assay) has been demonstrated to be a reliable test for estimating sensory irritancy of airborne irritants and RD50s are a basis, at least partially, for OELs by ACGIH (Kuwabara et al. 2007). ECHA guidelines (Chapter R.8) acknowledges the use of the Alarie assay in assessing respiratory irritation.
It was not possible to achieve an aerosol concentration high enough to result in a 50 % respiratory depression in mice for boric acid based on the results in the mouse sensory irritation model. The highest concentration of boric acid that was achievable with acceptable control of the aerosol concentration was 1096 mg/m³ with a % RD of 19 %. Based on these results, the RD50 is > 1096 mg/m³ for boric acid. The ASTM standard uses the value of 0.03 x RD50 for estimation of threshold limit values (TLV). Alarie et al. (2001) has established that a value of 0.01 x RD50 as the concentration where no sensory irritation would be seen in humans. Therefore, although the highest achievable concentration was below the RD50 value for boric acid, based on the high aerosol concentrations achieved with % RD values below 50 %, it is clear that boric acid is not a respiratory irritant or at worst has extremely low potency as a sensory irritant. The practical side of these results is that occupational exposure limit of 10 mg/m3 total particulate will prevent any sensory irritation in workers.
Read Across
A number of these studies were conducted on an analogue substance. Read-across is justified on the following basis: In aqueous solutions at physiological and acidic pH, low concentrations of simple inorganic borates such as boric acid B(OH)3, diammonium decaborate (B5H4NO8), disodium tetraborate decahydrate (Na2B4O7.10H2O; borax), disodium tetraborate pentahydrate (Na2B4O7.5H2O; borax pentahydrate), boric oxide (B2O3) and disodium octaborate tetrahydrate (Na2B8O13.4H2O) will predominantly exist as undissociated boric acid. Above pH 9 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is undissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as undissociated boric acid under the same conditions. For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance. Conversion factors are given in the table under CSR section 5.1.3, which corresponds to IUCLID section 7.1 (toxicokinetics, metabolism and distribution endpoint summary). References: WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998
Justification for classification or non-classification
No classification is required regarding skin or eye irritation as no irritating effects were observed on application to the skin or eyes of test animals.
All scores were under the cut-off values triggering classification and labelling. The criteria for a respiratory irritant. are also not met.
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