2-hydroxy-3-(prop-2-enoyloxy)propyl 2-methyl-2-propylhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 09, 2015 to June 26, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

typing error

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Molecular formula:

C16H28O5

IUPAC Name:

Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Constituent 2

Reference substance name:

Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Molecular formula:

C17H30O5

IUPAC Name:

Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Constituent 3

Reference substance name:

glycerol 1,3-dineodecanoate

Molecular formula:

C23H44O5

IUPAC Name:

glycerol 1,3-dineodecanoate

Constituent 4

Reference substance name:

Sum of other constituents, each of them at <1%

Molecular formula:

Not available

IUPAC Name:

Sum of other constituents, each of them at <1%

Test material form:

liquid

Specific details on test material used for the study:

Batch no.: JBGJ0045R
Appearance: clear yellowish liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Velaz Prague, Czech Republic
Age: At least 8-12 weeks; female animals were non-pregnant and nulliparous
Acclimatization: at least 5 days
Temperature: 22 ± 2°C, relative humidity : 55 ± 10% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany, ad libitum
Water: tap water for human consumption, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The required amount of the test substance (according to the body weight and dose) was mixed with vehicle (carboxymethyl cellulose - 1% solution) shortly before administration. The test substance was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test substance administered. After the test isubstance had been administered, food was withheld for further 3-4 hours.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males and 6 females

Control animals:

no

Details on study design:

- Animals were observed individually immediately after the administration of the test substance and then ½, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Individual weights of animals were determined shortly before the test substance was administered and at weekly thereafter. Weight differences after first and second week after application were calculated and recorded.
- All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.

Results and discussion

Preliminary study:

The starting dose was selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg bw. Available information indicated that the test substance is likely to be nontoxic considering to acute toxicity. A limit dose of 2000 mg/kg bw was used as starting dose. Group of 3 rat’s females were dosed. Test substance-related mortality was not produced during 24 hours; group of 3 rat’s females and group of 3 rat’s males were tested at the same dose.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

All 6/6 females and 3/3 males survived the limit dose 2000 mg/kg bw. No further dosing was necessary.

Clinical signs:

other: No mortality was observed during the study. Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.

Gross pathology:

All animals (6 females and 3 males) were necropsied. During necropsy, no macroscopically changes were noticed.

Any other information on results incl. tables

Based on the results, the test substance was classified in category 5/Unclassified with the cut off LD50 ≥ 5000 mg/kg bw, after single oral administration to Wistar rats.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Remarks:

does not need to be classified

Conclusions:

Under the study conditions, the rat LD50 was determined to be ≥ 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423, in compliance with GLP. The test substance was administered by gavage to 6 female and 3 male rats at a limit dose of 2000 mg/kg bw. All 6/6 females and 3/3 males survived the limit dose of 2000 mg/kg bw. No further dosing was necessary. No body weight losses were recorded one and two weeks after administration of the test substance. No important symptoms were observed at the dosage of 2000 mg/kg bw during first 4 h neither in females nor in males or in 14 day observation period. During necropsy, no macroscopically changes were noticed. Under the study conditions, the rat LD50 was determined to be ≥ 2000 mg/kg bw (Hozova, 2015).