Propylidynetrimethyl trimethacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 05 May to 11 June 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethyl trimethacrylate

EC Number:

221-950-4

EC Name:

Propylidynetrimethyl trimethacrylate

Cas Number:

3290-92-4

Molecular formula:

C18H26O6

IUPAC Name:

2,2-bis[(methacryloyloxy)methyl]butyl methacrylate (non-preferred name)

Test material form:

other: colourless liquid

Details on test material:

- Name of test material (as cited in study report): Propylidynetrimethyl trimethacrylate
- Physical state: colourless liquid
- Storage condition of test material: in a sealed container, at room temperature in the dark

Test animals

Species:

rat

Strain:

other: HsdHan:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: from 195 to 229 g
- Fasting period before study: overnight prior to dosing until 3 h after dosing
- Housing: in groups of up to five during the acclimatisation period. From the day prior to dosing (Day –1), the rats were housed in groups of three.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1 (Special Diets Services Ltd, Witham, UK ), ad libitum except during fasting period
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 21 to 23 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 May 2010 To: 11 June 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Volume applied: 1.82 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Preliminary study:

No data

Effect levels

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No clinical signs were seen.

Gross pathology:

Red foci on the thymus, a large mandibular lymph node and red foci on the mandibular lymph node were noted at necropsy on one animal.
No abnormalities were noted at necropsy of all other animals.

Other findings:

No data

Any other information on results incl. tables

Table 1: Individual body weights and weekly increments

Dose level (mg/kg bw)	Animal number	Body weight (g) at:					Increment (g)
		Day -1	Day 1	Day 4	Day 8	Day 15	Day 1 to 8	Day 8 to 15
2000	40	195	183	189	204	208	21	4
	41	229	217	220	244	257	27	13
	42	208	195	200	218	229	23	11
2000	43	209	201	209	215	225	14	10
	44	214	200	211	217	232	17	15
	45	216	208	217	221	236	13	15

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for propylidynetrimethyl trimethacrylate is higher than 2000 mg/kg bw in rats.

Executive summary:

In an acute oral class method toxicity study performed in accordance with GLP and OECD guideline 423, 6 Sprague Dawley female rats were given a single oral dose of propylidynetrimethyl trimethacrylate at the limit test dose of 2000 mg/kg bw.

Clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.

No mortality, no clinical signs, no change in body weight and no abnormalities in macroscopic examination of main organs were observed except red foci on the thymus, a large mandibular lymph node and red foci on the mandibular lymph node in one animal.

The oral LD50 for propylidynetrimethyl trimethacrylate is higher than 2000 mg/kg bw in rats therefore it is not classified according to the CLP Regulation (EC) N° 1272-2008.