Fatty acids, C14-18, C14-18-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. Lack of detail on test material

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of detail on test material

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C14-18, C14-18-alkyl esters

EC Number:

287-634-3

EC Name:

Fatty acids, C14-18, C14-18-alkyl esters

Cas Number:

85566-24-1

Molecular formula:

Not applicable as UVCB

IUPAC Name:

Fatty acids, C14-18, C14-18-alkyl esters

Details on test material:

- Name of test material (as cited in study report): [only trade name given]
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: Wistar-derived albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 156 - 232 g
- Fasting period before study: animals were fasted overnight prior to administration
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

no data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and signs of toxicity daily; the body weight was recorded on Day 0 prior to dosing and on Day 14.
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs and body weight.

Results and discussion

Effect levels

Sex:

male/female

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: other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings.

Any other information on results incl. tables

 Table 1: Summary of results

Dose (mg/kg bw)	Animal Number and Sex	Bodyweight (grams) (Day 0)	Clinical signs		Bodyweight (grams) (Day 14)
			Hours:	Days:
			1 - 24	2 - 14
5000	1M	204	N	N	322
	2M	201	N	N	318
	3M	192	N	N	302
	4M	176	N	N	265
	5M	156	N	N	240
	6F	210	N	N	252
	7F	214	N	N	267
	8F	216	N	N	278
	9F	232	N	N	296
	10F	232	N	N	292

N – Normal

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