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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)

Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Read across approach adequate to support 7.6.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: no data
Deviations:
not specified
Principles of method if other than guideline:
Boric acid was administered orally by gavage to six groups of five male and five female albino Sprague-Dawley rats. The test material was administered as a 50 % w/v suspension in 0.5 % aqueous methyl cellulose at dosage levels of 2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw. Rats were fasted for a period of 3 to 4 h prior to dosage. Animals were observed for mortality and toxic effects at 1, 2, 4, and 24 h and once daily after for a total of 14 days. At teh end of the observation period the surviving animals were weighed sacrificed and autopsies were performed.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Name of test material: Boric acid
- Substance type: Solid
- Physical state: Fine soft white powder
- Analytical purity: > 99 %
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
EST ANIMALS
- Weight at study initiation: Males: 267 - 302 g; Females: 214 - 248 g
Route of administration:
oral: gavage
Vehicle:
other: 0.5 % aqueous methyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % w/v

MAXIMUM DOSE VOLUME APPLIED: 3450 - 4080 mg/kg bw
Doses:
2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw.
No. of animals per sex per dose:
Five animals/group; no further data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs
Statistics:
Litchfield and Wilcoxon
Sex:
male
Dose descriptor:
LD50
Effect level:
3 450 mg/kg bw
Based on:
test mat.
95% CL:
> 2 950 - < 4 560
Remarks on result:
other: mg boric acid/kg
Sex:
female
Dose descriptor:
LD50
Effect level:
4 080 mg/kg bw
Based on:
test mat.
95% CL:
> 3 640 - < 4 560
Remarks on result:
other: mg boric acid/kg bw

Data source

Reference
Reference Type:
publication
Title:
The toxicology of some glycols and derivatives.
Author:
Laug E, Calvery HO, Morris HJ, Woodward G
Year:
1939
Bibliographic source:
Journal of Industrial Hygiene and Toxicology 21: 173 - 201

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
11160, 12555, 13950, 16740, 19530, 20925, 22320 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The animals were sacrificed after 5 days of observation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 16 500 mg/kg bw
Mortality:
yes
Clinical signs:
Thirst, diuresis, ruffled coat and refusal of food were reported. After the first 2 to 3 days there was cessation of urine excretion with heavy proteinuria. Prostration, dyspnea, bloated appearance, coma, and pronounced lowering of body temperature were reported for about 24 hours before death.
Gross pathology:
Histopathology:
- There was extensive degeneration of the renal cortex with vacuolar (hydropic) degeneration of the convoluted tubules.
- In the liver there was widespread diffuse hydropic degeneration of the central of lobules.
- The lung of some animals showed congestion, edema and focal interstitial pneumonia and hemorrhage in some cases.
- The spleen in many cases showed excessive phagocytosis of blood pigment

Applicant's summary and conclusion

Conclusions:
The available experimental animal data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No 1272/2008.