Lithium bis(oxalato)borate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-09-22 to 2011-10-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium-bis(oxalato)borate

IUPAC Name:

Lithium-bis(oxalato)borate

Constituent 2

Reference substance name:

Lithium bis(oxalato)borate

EC Number:

456-990-3

EC Name:

Lithium bis(oxalato)borate

Cas Number:

244761-29-3

Molecular formula:

C4BLiO8 (Hill Empirical Formula) C4BO8.Li (CAS Empirical Formula)

IUPAC Name:

boron(3+) lithium(1+) dioxalate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Crl(WI)Br
- Hygienic level: SPF at arrival
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Weight at study initiation: preliminary study 202-222g; main study, male: 279-293g; main study, female: 214-258g
- Housing: during acclimatisation: 3 animals/sex/cage; during study: individually housed
- Diet (e.g. ad libitum): ssniff® SM R/M-Z+H complete diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: preliminary study: 5 days; main study: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back of the animal
- % coverage: approximately 10 %
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with body temperature water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24 h

Doses:

preliminary study: 5, 50, 300, 2000 mg/kg bw
main study: 2000 mg/kg bw

No. of animals per sex per dose:

preliminary study: 2 female animals/dose
main study: 5 per sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations twice daily; body weight was recorded on day 0 (shortly before treatment), 7 and 15
- Necropsy of survivors performed: yes
- Clinical observations: were done individually 1h and 5 h after dosing and once each day for 14 days thereafter
- Pathology: all animals were exsanguinated after 14 days and subjected to gross pathology

Results and discussion

Preliminary study:

There were no deaths in the preliminary study at 5, 50, 300 and 2000 mg/kg bw dose levels.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred after the 24-hour dermal exposure to lithium bis(oxalato)borate (LiBOB) in Crl:(WI)BR male and female rats during the study.

Clinical signs:

other: General symptoms In males treated with the 2000 mg/kg bw dose porphyrin excretion around the eyes (4 cases of 80 observations) was observed. It was detected on the treatment day between 1 and 5 hours after the treatment. But all animals were free of symp

Gross pathology:

All animals survived until the scheduled necropsy on Day 15. No macroscopic alterations due to the systemic toxic effects of the test item were found.

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

Under the experimental conditions adopted, the application of lithium bis(oxalato)borate (LiBOB) for 24 hours to the skin of male/female Wistar rats does not cause mortality.

Executive summary:

An acute dermal toxicity study was performed with test item lithium bis(oxalato)borate (LiBOB) in Crl:(WI)BR rats, in compliance with OECD Guideline No.: 402, Directive 92/69 EEC B.3 and OPPTS 870.1200. A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to lithium bis(oxalato)borate (LiBOB) at 2000 mg/kg bw by dermal route. The test item was applied in original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight erythema and other signs (wounds, crusting and desquamation) between Day 1 and Day 10. Slight body weight loss was observed in three females on the first week. It could not be evaluated as a toxic effect of the test item. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. Under the experimental conditions, the acute dermal LD50 value of the test item lithium bis(oxalato)borate (LiBOB) proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. On the other hand, it is to be noted that the test item caused dermal irritation response on the site of administration. (TOXI-COOP, 2011)