(tris[2-(2-hydroxyethoxy)ethyl] borate )

Acute Toxicity: oral

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 for cross-reference:

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 for cross-reference:

read-across source

Qualifier:

according to guideline

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 or test system 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

Test material information

Constituent 1

Reference substance name:

2-(2-hydroxyethoxy)ethan-1-ol

Cas Number:

111-46-6

Molecular formula:

C4H10O3

IUPAC Name:

2-(2-hydroxyethoxy)ethan-1-ol

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.