10-Undecenoic acid, monoester with 1,2,3-propanetriol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 - 26 Dec 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study with acceptable restrictions. Only 5 males were used in the limit test, the observation period was 7 days. no gross pathology examination was performed, the mouse was used instead of the preferred species the rat, the test substance purity was not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

yes

Remarks:

only 5 males were used in the limit test, no gross pathology examination was performed, observation period was 7 days, the mouse was used instead of the preferred species the rat, the test substance purity was not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Pharmacopée Franҫaise IXe édition

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material: undecylenate de glycerol
- Physical state: Pale yellow gel
- Analytical purity: 100%
- Lot/batch No.: 18060502

Test animals

Species:

mouse

Strain:

other: NMRI Han EOPS

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: EVIC CEBA, Blanquefort, France
- Weight at study initiation: on average 20 g
- Fasting period before study: approximately 4 h
- Housing: animals were housed in groups of 5 in polypropylene cages (46.5 x 15.5 x 14 cm)
- Diet: UAR 113 pellets, ad libitum
- Water: tapwater, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: The animals were observed for mortality and clinical signs during 2 hours after administration and twice daily thereafter during the study period; the body weight was recorded prior to administration and on day 7 prior to sacrifice
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 7-day observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified