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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro gene mutation studies in bacteria (Stewart, 1991) in vitro gene mutation studies in mammalian cells (Rudd, 1991) and in vitro cytogenicity studies (NTP, 1987) concluded that boric acid is not genotoxic under the conditions of the studies.


 


Cytotoxicity observed at 5 mg/mL in the in vitro gene mutation studies in mammalian cells (Rudd, 1991).

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
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: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevent results.
Qualifier:
equivalent or similar to guideline
Guideline:
other: Carried out to an internal NTP protocol, which generally complies with OECD guidelines.
Deviations:
not applicable
Principles of method if other than guideline:
Although this was carried out to an internal NTP protocol, it generally complies with OECD guidelines. Other literature data confirm the results. Also based on Galloway et al; 1985.
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test
Target gene:
Not applicable
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix - Aroclor 1254 induced rat (Sprague-Dawley) liver S9 fraction
Test concentrations with justification for top dose:
With S-9: 500, 1000, 1500 and 2000 μg/mL.
Without S-9: 1000, 1600, 2000 and 2500 μg.
Vehicle / solvent:
Water
Positive controls:
yes
Positive control substance:
mitomycin C
Positive controls:
yes
Positive control substance:
cyclophosphamide
Details on test system and experimental conditions:
METHOD OF APPLICATION: In water
NUMBER OF CELLS EVALUATED: Not stated
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Conclusions:
Test substance is non genotoxic.
Endpoint:
in vitro gene mutation study in mammalian cells
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: 40 CFR Part 158 US-EPA-FIFRA, Section 156.340
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay
Target gene:
Thymidine kinase, TK locus of the L5178Y mouse lymphoma cell line
Species / strain / cell type:
mouse lymphoma L5178Y cells
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix or other (Aroclor 1254 induced rat (Fischer 344) liver S9 fraction used at 1 %).
Test concentrations with justification for top dose:
0, 1.2, 1.7, 2.45, 3.5 and 5.0 mg/mL boric acid.
Vehicle / solvent:
No data
Positive controls:
yes
Positive control substance:
3-methylcholanthrene
Positive controls:
yes
Positive control substance:
other: Hycanthone methylsulphonate
Details on test system and experimental conditions:
METHOD OF APPLICATION: ROP plus 5 % heat treated horse serum

NUMBER OF CELLS EVALUATED: Approximately 600/dose
Evaluation criteria:
Mutations at the TK locus
Statistics:
No data
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Concentration related cytoxicity (60 % reduction over controls at 5 mg/mL)
Additional information on results:
Concentration related cytotoxicity (60 % reduction over controls at 5 mg/mL).
Increase in ouabain resistance seen (not significant).

Gene mutation assay results:

Concentration

mg/mL

Number of mutant cells per 106cells ± SD

Comments give information

on cytotoxicity or other

Exp 1

Exp 2

Exp 1

Exp 2

-S9

-S9

+S9

+S9

0

54 ± 10

42 ± 1

29 ± 10

36 ± 7

 

1.2

46 ± 28

38 ± 15

34 ± 0

36 ± 7

 

1.7

39 ± 17

31 ± 9

41 ± 7

49 ± 4

 

2.45

27 ± 3

32 ± 9

40 ± 16

36 ± 6

Minor cytotoxicity seen

3.5

31 ± 18

46 ± 1

41 ± 13

41 ± 6

Cytotoxicity seen

5

50 ± 22

41 ± 5

53 ± 2

47 ± 3

Cytotoxicity seen. Increase in + S9 in first study not reproduced.

Conclusions:
The test substance was not mutagenic but cytotoxicity observed at 5 mg/mL (maximum dose level).
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-05-91 to 12-08-91
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevent results.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
There is a failure to justify the maximum concentration of 2500 µg/plate
Qualifier:
according to guideline
Guideline:
other: US EPA 40 CFR Part 158; FIFRA, Section 158.340
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EPA OPP 84-2
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9 at 4 % and 10 %
Test concentrations with justification for top dose:
10; 50; 100; 1000; 2500 μg/plate
Vehicle / solvent:
Water
Positive controls:
yes
Positive control substance:
sodium azide
Positive controls:
yes
Positive control substance:
9-aminoacridine
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Positive controls:
yes
Positive control substance:
other: 2-Anthramine
Details on test system and experimental conditions:
METHOD OF APPLICATION: In water

DURATION
- Preincubation period: None
Evaluation criteria:
No data
Statistics:
No data
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Additional information on results:
No data
Conclusions:
The study was performed according to Guideline 84-2 and is comparable to OECD 471. The test substance was not mutagenic in any of the strains tested with or without metabolic activation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

In addition, the results of an in vivo bone marrow cytogenetic assay (chromosome aberration assay, O’Loughlin 1991) also showed boric acid to be non genotoxic.

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
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: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Qualifier:
according to guideline
Guideline:
other: US-EPA-FIFRA section 158.340 Guideline 84-2
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
micronucleus assay
Species:
mouse
Strain:
Swiss Webster
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
Distilled water.
Details on exposure:
Mice given two doses (in 10 mL distilled water) by gavage.

Duration of treatment / exposure:
2 days.
Frequency of treatment:
Animals dosed once per day.
Post exposure period:
No data
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
225 mg/kg bw/day (actual dose received)
Dose / conc.:
450 mg/kg bw/day (actual dose received)
Dose / conc.:
900 mg/kg bw/day (actual dose received)
Dose / conc.:
1 800 mg/kg bw/day (actual dose received)
Dose / conc.:
3 500 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
No data
Control animals:
not specified
Tissues and cell types examined:
No data
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Clinical signs included rough fur and haunched position.
Conclusions:
Interpretation of results: negative
The test substance was not genotoxic.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

All the in vitro data indicate no mutagenic activity. In addition, the single in vivo study on boric acid also indicated no mutagenic activity.


Please also refer to the read-across statement attached to section 13.

Justification for classification or non-classification

No classification according to Regulation (EC) No 1272/2008 is required for sodium pentaborate regarding genotoxicity as all results for boric acid were negative in the tests.