Fatty acids, C16-18 and C18-unsatd., iso-Bu esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (analytical purity of the test substance not provided, juvenile animals, only 2 animals used per sex and dose)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

analytical purity of the test substance not provided, juvenile animals, only 2 animals used per sex and dose

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., iso-Bu esters

EC Number:

284-868-8

EC Name:

Fatty acids, C16-18 and C18-unsatd., iso-Bu esters

Cas Number:

84988-79-4

Molecular formula:

Not applicable (UVCB substance).

IUPAC Name:

Fatty acids, C16-18 and C18-unsatd., iso-Bu esters

Details on test material:

- Name of test material (as cited in study report): Isobutyloleat
- Physical state: clear, yellow liquid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: males: 178 g; females: 150 g
- Fasting period before study: yes, animals were fasted 16 hours prior administration and 3 hours after application
- Housing: 2 animals were housed in Makrolon 3 cages
- Diet: Altromin-Haltungsdiät 1324, Altromin GmbH, Lage, Germany, ad libitum
- Water: tap-water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% (g/v)
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed several times on the day of dosing and 2 times per day thereafter. Individual body weights were determined daily prior and on the day of application, on Day 7 and Day 14 after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalitites or clinical sigsn of adverse systemic toxicity observed at this concentration.

Mortality:

No mortality occurred during the study period.

Clinical signs:

No signs of systemic toxicity were observed during the 15-day observation period. Only slight pilo-erection was observed 1 - 2.5 hours after application.

Body weight:

No effect on body weight was noted.

Gross pathology:

No findings considered to be related to treatment.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified