[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 September 2006 to 1 November 2006

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

-

EC Number:

482-480-5

EC Name:

-

Cas Number:

1187571-02-3

Molecular formula:

(R2C5H4NO2)(0-3)(R3C3H5O3)(0-3)H(0-2)B

IUPAC Name:

Coconut oil reaction products with boric acid and diethanolamine

Test animals

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

Test system
Number of animals per group: 3 females
Total number of animals: 6 females
Age when treated: 11 weeks
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Environmental conditions
Conditions: Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Accommodation: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.

Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum.

Water: Community tap water from Füllinsdorf ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Animals were fasted for approximately 17 hours after dosing (access to water was
permitted). Food was provided again approximately 3 hours after dosing.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

2 groups of 3 females were dosed

Details on study design:

The animals were examined daily during the acclimatization period and mortality, viability and
clinical signs were recorded.

All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15.

Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.

Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All
animals were necropsied and examined macroscopically.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Hunched posture was noted in all animals at the 3-hour reading and persisted in three animals until the 5-hour reading.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an OECD 423 study the LD50 (female rat) is greater than 2000 mg/kg body weight.

Executive summary:

Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with the test substance by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was applied undiluted at a concentration of 0.95 g/mL and administered at a dosing volume of 2.11 mL/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period.

Hunched posture was noted in all animals at the 3-hour reading and persisted in three animals until the 5-hour reading.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were recorded at necropsy.

 

The LD50 (female rat) is greater than 2000 mg/kg body weight.