Propylidynetrimethyl trimethacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 05 to 08, 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 24 April 2002

Deviations:

yes

Remarks:

systemic effects not followed; animals not weighed at the end of the study

GLP compliance:

yes (incl. QA statement)

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: Clear colourless liquid

Details on test material:

- Name of test material (as cited in study report): TMPTMA
- Physical state: Clear colourless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322) (BCM IPS Limited, London, UK), ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Three males

Details on study design:

TEST SITE
- Area of exposure: Dorsal flank area
- Type of wrap if used: Test material (0.5 mL) was applied beneath a gauze (2.5 cm X 2.5 cm), placed directly on the test sites and then secured in position with surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24H

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- Very slight erythema was observed at the application sites which subsided within 24 hours
- See table 1 for individual animal scores

Other effects:

No

Any other information on results incl. tables

Table 1: Individual skin reactions

Rabbits No.		62 Male	63 Male	64 Male
Erythema/Eschar	1 hour	1	1	1
	24 hours	0	0	0
	48 hours	0	0	0
	72 hours	0	0	0
Mean (24 hours + 48 hours + 72 hours)		0	0	0
Oedema	1 hour	0	0	0
	24 hours	0	0	0
	48 hours	0	0	0
	72 hours	0	0	0
Mean (24 hours + 48 hours + 72 hours)		0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not skin irritating

Conclusions:

Under the test conditions, TMPTMA is not classified as irritating to the skin according to the CLP Regulation (EC) N° (1272-2008).

Executive summary:

In a primary dermal irritation GLP study performed according to OECD guideline 404, three New-Zealand white male rabbits were dermally exposed to 0.5 mL of TMPTMA, under a semi-occlusive bandage (25 cm X 25 cm) for 4 hours to clipped skin of dorsal flank area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize (1959).

 

Very slight erythema was observed at the application sites which subsided within 24 hours. Mean individual scores at 24, 48 and 72 hours after removal of the test material for the 3 animals were 0, 0, 0 for erythema/oedema score. In this study, TMPTMA is not a dermal irritant on male rabbits.

 

Under the test conditions, TMPTMA is not classified as irritating to the skin according to the criteria of the CLP Regulation (EC) N° 1272-2008.