Propylidynetrimethyl trimethacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 25 May to 16 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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 February 1987

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

fixed dose procedure

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:

male/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 12 weeks
- Weight at study initiation: from 279 to 344 g (males) and from 186 to 201 g (females)
- Housing: in groups of up to five during the acclimatisation period. From the day prior to dosing (Day –1), the rats were housed individually.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1 (Special Diets Services Ltd, Witham, UK ), ad libitum
- 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: 16 June 2010

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsum
- % coverage: 10 % of total body surface
- Type of wrap if used: A dense gauze patch was placed over the treated skin and retained in place by an elasticated, open-weave, adhesive compression bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): . The dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.82 mL/kg
- Constant concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

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. Individual records of clinical signs were maintained for each treated rat. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- One male and one female were used for preliminary test (results included in the main test)

Statistics:

None

Results and discussion

Preliminary study:

No mortality found.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality found.

Clinical signs:

other: There were no clinical signs of reaction to treatment. No dermal reactions were noted.

Gross pathology:

Red foci on the thymus, red foci on the mandibular lymph nodes and pale kidneys were noted at necropsy of in one male. Large mandibular lymph nodes and pelvic dilatation of the kidneys were noted in one female.
No macroscopic changes were observed at necropsy of all other animals.

Other findings:

No data

Any other information on results incl. tables

Table 2: individual body weights

Dose level (mg/kg)	Animal number and sex	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	30M	275	279	285	297	317	18	20
	31M	322	324	315	326	334	2	8
	32M	289	285	285	291	304	6	13
	33M	339	341	332	340	351	-1	11
	34M	339	344	343	354	371	10	17
2000	35F	201	201	204	206	219	5	13
	36F	200	196	197	201	212	5	11
	37F	187	189	184	191	195	2	4
	38F	194	191	190	191	204	0	13
	39F	186	186	185	187	201	1	14

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, propylidynetrimethyl trimethacrylate is not classified according to the criteria of CLP Regulation(EC) N° (1272-2008).

Executive summary:

Propylidynetrimethyl trimethacrylate was tested for acute dermal toxicity in wistar rats in a limit dose assay, according to OECD guideline 402 in compliance with GLP. Groups of rats (5/sex) were administered a single dermal dose of propylidynetrimethyl trimethacrylate at 2000 mg/kg bw on clipped skin using a semi-occlusive patch for 24 h. Examinations for mortality, clinical signs and body weight gain were performed during a 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths and clinical signs occurred during the observation period. All rats gained weight over of the study period. Red foci on the thymus, red foci on the mandibular lymph nodes and pale kidneys were noted at necropsy in one male. Large mandibular lymph nodes and pelvic dilatation of the kidneys were noted in one female. No cutaneous reactions were recorded in any animal throughout the observation period. The acute dermal LD50 for males and females was greater than 2000 mg/kg bw. Under the test conditions, propylidynetrimethyl trimethacrylate is not classified according to the criteria of the CLP Regulation (EC) N° 1272-2008.