Isohexadecyl 12-[(1-oxooctadecyl)oxy]octadecanoate

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

Remarks:

Limited data on materials and method, test substance purity not specified.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Report date:

1983

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

yes

Remarks:

limited data on materials and method, test substance purity not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, USA
- Weight at study initiation: 350.0 g (males), 174.0 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: individual, in wire mesh bottom cages
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
Animals were housed in environmentally controlled rooms.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 8.20 mL (males), 3.96 mL (females)

Doses:

20 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: animals were observed for clinical signs 'frequently' on the day of administration and daily thereafter; body weight was recorded on Day 1 (prior to administration) and Day 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the 15-day observation period.

Clinical signs:

5/5 males and 5/5 females had diarrhoea 1 and 4 h after administration. On Day 2, 2/5 females had apparent urinary incontinence, one of these females also showed decreased activity. 1/5 females had soft stool on Day 2. No clinical signs were observed from Day 3 onwards.

Body weight:

Body weight gain in males and females were within the range expected for rats of this strain and age used in this type of study.

Gross pathology:

No substance-related findings were observed at the necropsy and histopathological examination.

Any other information on results incl. tables

Table 1. Acute oral toxicity

Dose [g/kg bw]	Mortality	Clinical signs
	N*	N*
Males
20	0/5	5/5
Females
20	0/5	5/5

*N= Number of animals/ number of animals used

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.