Registration Dossier
Registration Dossier
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EC number: 215-575-5 | CAS number: 1332-77-0
Endpoint summary
Administrative data
Description of key information
Boric acid was tested in a Buehler method skin sensitisation test according to OECD 406 (Wnorowski, 1994) applied at a concentration of 95 % (powder moistened with water) during both the induction and challenge phase of the test. No signs of skin sensitisation were observed. No evidence of skin sensitisation in humans exposed occupationally to borates has been reported (Bruze et al., 1995).
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 Guideline 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: 256-441 g - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 g 95 % w/w substance.
- Route:
- other: Not specified
- Vehicle:
- water
- Concentration / amount:
- 0.4 g 95 % w/w substance.
- 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:
- A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Day 0, Day 7 and Day 21
- Test groups: 0.4 g 95 % w/w substance moistened with distilled water to enhance skin contact.
- Frequency of applications: Day 0, Day 7 and Day 21
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: After 6 hours test substance wiped off with water
- Concentrations: 95 % w/w substance moistened with distilled water to enhance skin contact
- Evaluation: 24h & 48 h - Challenge controls:
- No data
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 g 95 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 g 95 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not specified
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not specified
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- A study was performed according to OECD Guideline 406 "Skin Sensitisation" method (Buehler test) using 95 % w/w disodium tetraborate pentahydrate moistened with distilled water to enhance skin contact. No irritation was observed.
- 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:
- 24
- 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
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 g 95% w/w/boric acid
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Interpretation of results:
- other: EU GHS criteria not met
- 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.
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)
- Additional information:
No skin sensitisation studies with dipotassium tetraborate were available, however, studies were conducted on analogue substances. Disodium tetraborate decahydrate, disodium tetraborate pentahydrate and boric acid were tested in a Buehler method skin sensitisation test following OECD 406 (Wnorowski, 1994) applied at a concentration of 95 % (powder moistened with water) during both the induction and challenge phase of the test. No signs of skin sensitisation were observed.
Please also refer to the read-across statement attached to section 13.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no data to suggest that dipotassium tetraborate is a respiratory sensitiser.
Justification for classification or non-classification
Boric acid is not a skin or respiratory sensitiser. In accordance with the criteria of EU Regulation (EC) No 1272/2008 Dipotassium tetraborate does not need to be classified and labelled as a skin or respiratory sensitiser.
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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