[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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: Guideline study.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: inhalation

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 403 (Acute Inhalation Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: USEPA FIFRA 40 CFR Part 160

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animlas Inc, Boyertown, PA
- Age at study initiation: Young adult
- Weight at study initiation: Males 205 - 255 g, females 179 - 208 g

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD 3.5 μm ± GSD 1.81 μm


CLASS METHOD
- Rationale for the selection of the starting concentration: ~ 2mg/L was the highest that was obtainable under the conditions of the test.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

Nominal concentration: 2000 mg/m3
Analytical concentration: 2120 ± 140 mg/m3

No. of animals per sex per dose:

5/sex/dose

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:

Not applicable - limit test

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.12 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: This study was carried out at the request of the US EPA to confirm that the highest dose obtainable was 2 mg/L. It was deemed by the US EPA to be an acceptable study.

Mortality:

No deaths occurred

Clinical signs:

other: Animal observations were limited to the accumulation of test material on the walls of the exposure chamber. During the first 1.5 h of exposure, ocular and nasal discharge, hypoactivity and hunched posture were noted. Ocular discharge and/or nasal discha

Body weight:

No data

Gross pathology:

No specific findings observed, except red lung discolouration consistent with carbon dioxide inhalation caused by the euthanisation technique. All tissues and organs were normal.

Other findings:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

The test was performed according to OECD Guideline 403. No deaths occurred. Animal observations were limited due to the accumulation of test material on the walls of the exposure chamber. During the first 1.5 h of exposure, ocular and nasal discharge, hypoactivity and hunched posture were noted. Ocular discharge and/or nasal discharge persisted in most animals after removal from the chamber. All animals recovered by day two after removal from the chamber.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FIFRA (40 CFR 163)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: USEPA FIFRA 40 CFR Part 160

Deviations:

not specified

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

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

Details on test material:

- Name of test material: Boric acid
- Molecular formula: H3BO3
- Molecular weight: 61.8
- Smiles notation: B(OH)3
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: > 99.9 % w/w
- Stability under test conditions: Stable
- Lot/batch No.: OA 107-3
- Other: White and odourless

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan F. Plummer
- Weight at study initiation: 1623 - 2922 g

Administration / exposure

Vehicle:

physiological saline

Duration of exposure:

24 h

No. of animals per sex per dose:

5/sex/group

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, histopathology

Statistics:

Not applicable - limit test.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

other: Clinical changes were limited to transient diarrhoea in 2 rabbits and some incidences of erythema (9), and oedema (30), atonia (2), desquamation (4), necrosis, and other evidence of irritation at 23 and ~70.5 h after treatment.

Gross pathology:

No gross necrospy findings were observed. Observations included one animal with gas filled intestine, one animal with pale yellow-coloured kidneys and 5 animals with enlarged or swollen fallopian tubes.

Other findings:

No data

Any other information on results incl. tables

Gross necropsy findings in male and female rabbits at the end of the observation period:

Gross Necropsy Findings	Dosage at 2 g/kg
Number of animals necropsied	10
No gross necropsy findings	5
Intestine
Gas-filled	1
Kidneys
Pale yellow coloured	1
Fallopian tubes
Enlarged or swollen	4
Pale	1
External
Diarrhoea stains	1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study was performed according to FIFRA (40 CFR 163). The LD50 > 2000 mg/kg bw indicating no acute dermal toxicity. No deaths occurred. Clinical changes were limited to erythema, oedema, atonia, desquamation, necrosis and some incidences of skin irritation at more than 24 h of treatment.