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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
neurotoxicity: acute oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2011-06-24 to 2011-07-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.6200 (Neurotoxicity Screening Battery)
Deviations:
no
GLP compliance:
yes
Remarks:
FIFRA standards; Code of Federal Regulations (CFR) Title 40, Part 160.
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Boric acid
EC Number:
233-139-2
EC Name:
Boric acid
Cas Number:
10043-35-3
Molecular formula:
H3BO3
IUPAC Name:
Boric acid
Test material form:
other: solution
Details on test material:
- Name of test material (as cited in study report): boric acid
- Substance type: inorganic acid
- Physical state: white, odorless, crystalline solid
- Analytical purity: 99% (56.37% B203; boron oxide)
- Purity test date: 2011-08-24
- Lot/batch No.: 8C20
- Stability under test conditions: stable

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1% (w/v)
Details on exposure:
The test substance was administered in a vehicle of 1% (w/v) aqueous carboxymethyl cellulose to Group 1and 2 animals at respective dose levels of 0 or 2000 mg/kg.
Experimental endpoints consisted of moribundity/mortality and clinical observations, body weights and body weight gains, functional observation battery and motor activity evaluations, post-fixation brain weights, and gross necropsy and neurohistopathologic observations.
Analytical verification of doses or concentrations:
yes
Frequency of treatment:
single administration
Doses / concentrations
Dose / conc.:
2 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Remarks:
Neurotoxicity
Effect level:
2 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'
Remarks on result:
other:

Applicant's summary and conclusion

Conclusions:
Boric acid was not neurotoxic up to 2000 mg/kg bw in rats.
Executive summary:

Boric acid was administered to male and female rats to evaluate the potential neurotoxicity of the test substance following a single oral gavage dose (followed by a 14-day observation period). The test substance was administered in a vehicle of 1 % (w/v) aqueous carboxymethyl cellulose to Group 1 and 2 animals at respective dose levels of 0 or 2000 mg/kg. Experimental endpoints consisted of moribundity/mortality and clinical observations, body weights and body weight gains, functional observation battery and motor activity evaluations, post-fixation brain weights, and gross necropsy and neurohistopathologic observations. Administration of the test substance at 2000 mg/kg resulted in no mortality or adverse clinical signs. Total body weight gain in the boric acid-treated male rats was decreased 16% compared to the control group at the end of the 14-day observation period. Functional observation battery and motor activity evaluations did not show any evidence of neurotoxicity in either sex. No neurohistopathology findings (gross lesions or treatment-related microscopic findings) were observed in either sex. In conclusion, a single oral (gavage) dose of boric acid at a level of 2000 mg/kg to male and female rats was not neurotoxic.