Fatty acids, C16-18, 2-butyloctyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-02-07 - 2005-02-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, 2-butyloctyl esters

EC Number:

309-831-6

EC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Cas Number:

101227-08-1

Molecular formula:

C28H56O2 - C30H60O2

IUPAC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Constituent 2

Reference substance name:

Fatty acid, C16-18, 2-Butyloctylester

IUPAC Name:

Fatty acid, C16-18, 2-Butyloctylester

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ISOFOL ESTER 1202
- Physical state: yellow liquid
- pH: not applicable
- volatility: not volatile at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Oeutschland GmbH, 0-97633 Sulzfeld
- Age at study initiation:
- Weight at study initiation: 145-155 g
- Fasting period before study: overnight prior to dosing
- Housing: The rats were kept in transparent polycarbonate cages (macrolone type Ill, floor area 810 cm2) with two or three in each cage. The cages were cleaned and the bedding changed at least twice a week. Bedding was pinewood sawdust "Lignocel-Fasern" from Aliromin, 0-32791 Lage,
Lippe. Regular analyses for relevant possible contaminants are performed. Certificates of analysis are retained.
- Diet (e.g. ad libitum): A pelleted complete rodent diet "Altromin 1314" from Altromin GmbH, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet and certificates are retained.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for possible contaminants are performed regularly. Certificates of analysis are retained.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C +- 3 °C
- Humidity (%): 55+-15 %
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 2015-02-01 - 2015-02-24

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

2000 mg/kg

No. of animals per sex per dose:

1 rat in the preliminary study.
4 rats in the main study.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 30 min., 2, 4 and 6 hours after the administration and
thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0,7 and 14.
- Necropsy of survivors performed: All rats were killed by inhalation of CO2 on day 14 and subjected to a gross necropsy
examination.
- Other examinations performed: clinical signs

Statistics:

not mentioned

Results and discussion

Preliminary study:

One female rat was given ISOLFOL ESTER 1202 in a 2000 mg/kg b.w. dose. Slight signs of toxicosis were observed in this rat. Animal No. 1 showed a hunched posture and piloerection 30 min, 2 and 4 hours after the application of the test item. After 6 hours piloerection was still obseNed. Fromday 1 to the end of the obseNation period on day 14 no abnormalities were revealed. The post mortem inspection revealed no pathological abnormalities.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test, 2000 mg/kg bw is the only dose tested

Mortality:

No mortalities were obserded.

Clinical signs:

Animals No. 2, No. 3, No. 4 and No. 5 showed a hunched posture and piloerection 30 min and 2 hours after the application of the test item. After 4 hours piloerection was still obseNed. On day 0 after 6 hours and from day 1 to the end of the observation period on day 14 no abnormalities were revealed.

Body weight:

no effects, normal body weight gain

Gross pathology:

The post mortem inspection revealed no pathological abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Under the experimental conditions described in this final report the LD50 of ISOLFOL ESTER 1202 according to OECD 420 was > 2000 mg/kg.

Executive summary:

The acute oral toxicity of Fatty acids, C16-18 (even numbered), 2-butyloctyl esters was determined in 4 female Wistar rats each receiving 2000 mg/kg bw of the test material by oral gavage (limit test). The observation period was 14 days.

 

None of the animals died.

 

The acute oral LD50 was determined to be > 2000 mg/kg bw in rats.

 

This study is considered acceptable. It follows the principles of the retracted OECD test guideline 420 (Acute Oral Toxicity).