diethylmethoxyborane

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Information from migrated NONS file.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-380-9

EC Name:

-

Cas Number:

7397-46-8

Molecular formula:

C5H13BO

IUPAC Name:

methyl diethylborinate

Test animals

Species:

rat

Strain:

Wistar

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Remarks:

dry

Duration of treatment / exposure:

28 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 5 mg/kg bw/day
Male: 5 animals at 25 mg/kg bw/day
Male: 5 animals at 125 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 5 mg/kg bw/day
Female: 5 animals at 25 mg/kg bw/day
Female: 5 animals at 125 mg/kg bw/day

Results and discussion

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

5 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

Dose descriptor:

NOEL

Effect level:

5 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Clinical observations:

At 5 mg/kg/day: No treatment related findings noted.

At 25 mg/kg/day: Only slightly low body weights were found in females in week 4.

At 125 mg/kg/day: All animals died or were killed in extremis between day 9 and 10 of treatment. Prior to death or to sacrifice, hunched posture, uncoordinated movements, pale skin, quick breathing, ptosis and/or piloerection were observed in all females. Body weight and food consumption were reduced in week 1.

Laboratory findings:

At 5 mg/kg/day: No treatment related findings noted.

At 25 mg/kg/day: A decrease in erythrocyte cell count, haemoglobin and haematocrit in females only.

At 125 mg/kg/day: No clinical laboratory investigations were performed on the animals from this dose group, due to mortality or interim sacrifice of the animals.

Effects in organs:

At 5 mg/kg/day: No treatment related effects found

At 25 mg/kg/day: No treatment related effects found.

At 125 mg/kg/day: Macroscopic post mortem examination of the animals revealed changes in the stomach, liver, kidneys, adrenal glands, spleen, mesenteric lymph node and lungs. Microscopic correlations to the findings noted at macroscopic examination were found in the stomach (hyperplasia with hyperkeratosis, inflammation), liver (vacuolation, hypertrophy, pigment deposits), spleen (haemopoiesis) and mesenteric lymph nodes (hyperplasia).