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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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-[(9Z)-octadec-9-enoyloxy]propoxy}boronic acid 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
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.
Body weight:
There was no significant difference noted between the bodyweights of the treated and control animals.
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.