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Diss Factsheets
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EC number: 205-760-9 | CAS number: 150-46-9
- 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
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Endpoint summary
Administrative data
Description of key information
An OECD Guide-line 406 "Skin Sensitisation" method (Buehler test ) was performed using 95 % w/w boric acid moistened with distilled water to enhance skin contact. Very faint erythema was observed in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effects were observed therefore the test substance was considered a non-sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- OECD Guide-line 406 "Skin Sensitisation" method (Buehler test ) was performed before the LLNA was set as preferred test method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson’s Mill Farms, South Brunswick, NJ
- Age at study initiation: Young adult
- Weight at study initiation: Males: 314 -411 g; females: 282-376 g - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid - No. of animals per dose:
- Test Group: 20 animals
Naive Control: 10 animals
Positive Control: 20 animals
Positive Naive Control: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Concentrations: 0.4 g 95 % w/w boric acid moistened with distilled water to enhance skin contact.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: Test substance was wiped off with water after 6 h. - Challenge controls:
- No data
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
- Positive control results:
- No data
- Reading:
- 1st reading
- Hours after challenge:
- 34
- Group:
- test chemical
- Dose level:
- 0.4 g 95% w/w/boric acid
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 34.0. Group: test group. Dose level: 0.4 g 95% w/w/boric acid . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- OECD Guide-line 406 "Skin Sensitisation" method (Buehler test ) was performed using 95 % w/w boric acid moistened with distilled water to enhance skin contact. Very faint erythema was observed in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effects were observed therefore the test substance was considered a non-sensitiser.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Reason / purpose for cross-reference:
- reference to other study
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Observations:
Treatments |
Buehler test |
Observations/Remarks |
|
Day of treatment |
|
Induction 1 |
day 0 |
Very faint erythema (0.5) observed at one test site at 24 hours after first induction dose. No other irritation observed |
Induction 2 |
7 |
No irritation observed |
Induction 3 |
14 |
No irritation observed |
Challenge |
28 |
No irritation observed |
Scoring 1 |
29 |
Very faint erythema (0.5) observed at two test sites at 24 hours after challenge dose. Irritation persisted at one site for 48 hours. Very faint erythema (0.5) observed at one test site at 24 hours in one naive control. |
Scoring 2 |
30 |
|
Results of skin sensitisation test:
|
Number of animals with signs of allergic reactions / |
||
|
Negative control |
Test group |
Positive control |
scored after 24h |
0 / 10 |
0 / 20 |
10/20 |
scored after 48h |
0 / 10 |
0 / 20 |
7/20 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Boric acid is not a skin sensitiser. In accordance with the criteria of EU CLP Regulation (EC) No. 1272/2008) boric acid does not need to be classified and labelled as sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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