9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 August 1981 to 20 August 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)

EC Number:

264-092-6

EC Name:

9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)

Cas Number:

63310-16-7

Molecular formula:

C21H39O5B (based on the representative structure below)

IUPAC Name:

2-hydroxy-3-{[hydroxy({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}propyl (9Z)-octadec-9-enoate; 3-{[bis({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}-2-hydroxypropyl (9Z)-octadec-9-enoate; {2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy}boronic acid

Test material form:

not specified

Details on test material:

- Physical state: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Simonsen Laboratories, Gilroy, California, USA
- Age at study initiation: 70 days (males); 89 days (females)
- Weight at study initiation: 260 - 312 g (males); 217 - 241 g (females)
- Fasting period before study: overnight, prior to dosing
- Housing: individually in wire-bottom cages
- Diet: Purina Laboratory Rodent Chow #5001 ad libitum
- Water: ad libitum
- Acclimation period: 24 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21 ºC
- Humidity (%): 64 - 77 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 6 August 1981 to 20 August 1981

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSE VOLUME ADMINISTERED
The mean volumes of test material administered were 1.5 mL (males) and 1.2 mL (females)

Doses:

0 (control), 5.0 g/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosing and at least once each morning and late afternoon on each subsequent day (except at weekends when observations were made once daily). Bodyweights were recorded prior to dosing and on 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: animals were examined for gross pathological changes. The following organs and tissues were examined: skin, spleen, pancreas, stomach, small and large intestine, liver, adrenals, kidneys, gonads, uterus or seminal vesicles, bladder, heart, thymus, salivary glands, lungs, trachea, thyroid and fat.

Statistics:

The body weights of the treated animals were compared to controls using Student's t-test.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study.

Gross pathology:

At necropsy, no gross pathological changes attributable to treatment with the test material were observed.

Any other information on results incl. tables

Table 1: Mean (± s.d) bodyweights (g)

Group	Pre-test	7 days	14 days
Control males	187 (17)	350 (29)	359 (28)
Treated males	290 (16)	347 (24)	355 (27)
Control females	229 (8.3)	259 (8.8)	262 (9.7)
Treated females	230 (8.8)	262 (8.8)	266 (8.5)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the acute oral toxicity of the test material was determined to be in excess of 5000 mg/kg. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The acute oral toxicity of the test material was determined following a methodology equivalent to that in standardised guidelines OECD 401 and EU Method B.1.During the study, 5 male and 5 female rats were treated with 5000 mg/kg test material and another group of 5 male and 5 female rats served as controls. Under the conditions of the study none of the animals died, no clinical signs were reported and the bodyweights of the treated animals were comparable to those of the controls. No gross pathological changes attributable to treatment with the test material were observed in any of the animals, at necropsy. The acute oral LD50 of the test material was subsequently determined to be in excess of 5000 mg/kg.