Undec-10-enoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-03-24 till 1999-04-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according 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:

Undec-10-enoic acid

EC Number:

203-965-8

EC Name:

Undec-10-enoic acid

Cas Number:

112-38-9

Molecular formula:

C11H20O2

IUPAC Name:

undec-10-enoic acid

Details on test material:

- Physical state: colorless liquid
- Analytical purity: 99.4%
- Expiration date of the lot/batch: 1999/07
- Storage condition of test material: stored in dark at RT
-Batch 9807016 filling 41/99

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, L`Arbresle, France
- Age at study initiation: appr. 6 weeks
- Weight at study initiation: 174 +/-7g (males) 135+/-5g females
- Fasting period before study: appr. 18 h (acess to water)
- Housing: sex-separated in groups on dust-free sawdust in polcarbonate cages
- Diet / Water (e.g. ad libitum): ad lib. except for fasting
- Acclimation period: >5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

10 ml/ kg BW

Doses:

2000 mg/kg BW

No. of animals per sex per dose:

5

Control animals:

other: historical control

Details on study design:

no

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

Animals were observed for clinical signs and mortality frequently on the day of application, and afterwards once a day for 15 days;none during the whole study.

Clinical signs:

other: Animals were observed for clinical signs and mortality frequently on the day of application, and afterwards once a day for 15 days; hypoactivity and piloerection in one male and one female on day 1 only; no effect on other animals.

Gross pathology:

on day 15: no apparent abnormalities.

Other findings:

no

Any other information on results incl. tables

Table 1: Mean bodyweights (BW)

	historical control	study (2000 mg/kg bw)
MALES Initial BW	182	174
MALES BW day 15	315	295
FEMALES Initial BW	147	135
FEMALES BW day 15	215	193

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the dermal LD0 of the test substance ACIDE UNDECYLENIQUE is equal or higher than 2000 mg/kg in rats.

Executive summary:

The acute oral toxicity of the test substance ACIDE UNDECYLENIQUE was evaluated in rats according to OECD guideline No. 401 and EU directive 92/69/EEC B.1. The substance was applied to ten (five male and 5 female) Sprague-Dawley rats at a dose of 2000 mg/kg bw. Animals were observed for 15 days. Transient clinical signs (hypoactivity and piloerection) were present in two out of ten animals on the day of treatment only. Mortality, reduction of body weight gain and abnormalities in gross pathology were not evident.

Under the experimental conditions, the dermal LD0 of the test substance ACIDE UNDECYLENIQUE is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.