Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 Jan – 17 Feb 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP – Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom, UK

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C36 fatty diol

EC Number:

604-608-2

Cas Number:

147853-32-5

Molecular formula:

not available UVCB

IUPAC Name:

C36 fatty diol

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: colourless viscous liquid
- Substance type: UVCB
- Analytical purity: 100%
- Composition of test material, percentage of components: monomeric alcohol, 1.7%; dimer (1.5-mer incl.) alcohol, 97.2%; trimer alcohol, 1.1%
- Purity test date: 22 Dec 2003
- Lot/batch No.: 091728
- Storage condition of test material: room temperature, in the dark

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl:CD® (SD) IGS BR)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 193 – 216 g
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed in groups of 3 per cage in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: certified Rat and Mouse Diet (Code 5LF2; BCM IPS Limited, London, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Example: 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: arachis oil BP

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the test material did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The author stated that using all available information on the toxicity of the test material, 2000 mg/kg bw was chosen as the starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females (3 per testing step)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 30 min, 1, 2 and 4 h after dosing and subsequently daily for 14 days and individual body weights were determined prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: experimental result

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off according to OECD 423

Mortality:

No mortality occurred during the study period.

Clinical signs:

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

Gross pathology:

Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1. Individual body weights and body weight changes.

Dose Level mg/kg bw	Animal Number and Sex	Body weight (g) at Day			Body weight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Female	201	247	263	46	16
	1-1 Female	210	268	306	58	38
	1-2 Female	216	253	272	37	19
	2-0 Female	206	258	276	52	18
	2-1 Female	200	240	260	40	20
	2-2 Female	193	243	259	50	16

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