Boric acid (H3BO3), solid soln. with strontium oxide, europium-doped

Endpoint summary

Description of key information

Acute toxicity (oral): LD50 (female) > 5000 mg/kg bw (OECD 423/GLP)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Zhejiang Jingneng Phosphor Material Co., Ltd; 170825
- Expiration date of the lot/batch: 24 August 2019
- Purity: 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light

Species:

rat

Strain:

other: WISTAR rats Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8–10 weeks
- Weight at study initiation: Step 1: 144 – 164 g; Step 2: 152 – 161 g (on the day of administration)
- Fasting period before study: Animals were fasted; period not specified
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22  3 °C
- Humidity (%): 55  10%
- Air changes (per hr): Air change: 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage):1.4-1.6 mL
- Justification for choice of vehicle: This vehicle was chosen due to its non-toxic characteristics and the solubililty of the test item.
- Lot/batch no. (if required): lot no. 710745, expiry date: 30/09/2020


MAXIMUM DOSE VOLUME APPLIED: For all animals of the first step, 2053 g of the test item was suspended with the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg bw at a dose volume of 10 mL/kg body weight. For all animals of the second step, 2024 g of the test item was suspended with the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg bw at a dose volume of 10 mL/kg body weight.


DOSAGE PREPARATION: The test item was weighed out into a tared plastic vial on a precision balance. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 per step (2 steps)

Control animals:

no

Details on study design:

- Duration of observation period following administration: All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: Yes; All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
- Other examinations performed: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

There were no mortalities.

Clinical signs:

There were no clinical signs.

Body weight:

None of the animals showed weight loss during the observation period.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in female rats, the LD50 was >5000 mg/kg bw.

Executive summary:

In an acute oral toxicity test (185429), 3 female Wistar Crl: WI(Han) rats (2 groups) were administered boric acid (H3BO3), solid soln. with strontium oxide, europium-doped (99%) in water by oral gavage at a dose of 2000 mg/kg bw.

LD50 (female): >5000 mg/kg bw

There were no mortalities at any step. There were no clinical signs. None of the animals showed weight loss during the observation period. No specific gross pathological changes were recorded for any animal.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

There is one study available and it is an OECD guidelone/GLP study.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is one acute oral toxicity study in rats available.

In an acute oral toxicity test (OECD 423/GLP), 3 female Wistar Crl: WI(Han) rats (2 groups) were administered boric acid (H3BO3), solid soln. with strontium oxide, europium-doped (99%) in water by oral gavage at a dose of 2000 mg/kg bw. There were no mortalities at any step. There were no clinical signs. None of the animals showed weight loss during the observation period. No specific gross pathological changes were recorded for any animal. The LD50 (female) was >5000 mg/kg bw.

Justification for classification or non-classification

Based on the available information in the dossier, the substance boric acid (H3BO3), solid soln. with strontium oxide, europium-doped (CAS No. 102110-29-2) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.