Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

Use of 2000 mg/kg bw as limit dose. Use of 2 animals per sex.

GLP compliance:

no

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., isooctyl esters, epoxidized

EC Number:

307-159-8

EC Name:

Fatty acids, C16-18 and C18-unsatd., isooctyl esters, epoxidized

Cas Number:

97553-05-4

Molecular formula:

Unspecified

IUPAC Name:

Fatty acids, C16-18 (even numbered, C18 unsaturated), isooctyl esters, epoxidized

Test material form:

liquid

Specific details on test material used for the study:

- in the study report the old CAS 68082-34-8 number is given
- Name of test material (as cited in study report): Edenol B35 (neu)
- Chemical name: 2-Ethylhexyl-Epoxystearate
- Physical state: liquid, light yellow
- Analytical purity: 100%
- Lot/batch No.: 273

Test animals

Species:

rat

Strain:

Wistar

Remarks:

TNO

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen (district Paderborn)
- Age at study initiation: 152 g (females), 174 g (males)
- Weight at study initiation: at least 6 weeks
- Fasting period before study: 15 hours before treatment until 3 hours post-treatment
- Housing: 2 rats per Makrolon cage (type III)
- Diet: Altromin 1324 pellets, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50-70
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2%

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

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: 14 days
- Frequency of observations for mortality and symptoms: Several times at the day of application, twice daily afterwards.
- Frequency of weighing: Day -1 before fasting, day of application as well as 48 hours, 1 week, and 2 weeks after application.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Directly after application: piloerection, lethargy Day 2-3: lethargy

Gross pathology:

No findings.

Any other information on results incl. tables

Table 1: Development of body weights of rats during the acute oral toxicity study.

Animal No.	Sex	Day -1	Day of application	Day 2	Day 7	Day 14
1	Male	182	173	184	203	236
2	Male	190	175	186	208	228
1	Female	155	149	157	164	166
2	Female	164	154	160	156	169

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality occurred and no gross pathology findings were observed.

Executive summary:

In an acute oral toxicity study equivalent to OECD TG 401 (adopted 1981, no GLP), the test substance was administered by oral gavage to two Wistar rats of each sex at 2000 mg/kg bw as a limit dose. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 15 days. Clinical signs of toxicity, body weights as well as gross pathological findings were recorded. Directly after application piloerection and lethargy were observed as clinical signs. Lethargy was present at day 2 and 3 after administration. No animals died on account of the treatment nor did they show severe signs of toxicosis in the 14 observation period. The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg bw.