Propylidynetrimethyl trimethacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 11 to 21, 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no data on non-ocular local and systemic adverse effects

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume with unit): 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not applicable

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Eye examinations were performed using light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

for each animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

for each animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

for each animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

- Minimal conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment and in one treated eye at the 48 hour observation; irritation completely resolved within 72 hours
- See table 1 and 2 for further details

Other effects:

No data

Any other information on results incl. tables

Table 1: Individual eye irritation scores

Animal	Time after dosing (hours)	Cornea		Iris	Conjunctivae
		Opacity	Area		Redness	Chemosis	Discharge
126 Male	1	0	0	0	1	0	1
	24	0	0	0	1	0	0
	48	0	0	0	1	0	0
	72	0	0	0	0	0	0
30 Male	1	0	0	0	1	1	1
	24	0	0	0	1	0	0
	48	0	0	0	0	0	0
	72	0	0	0	0	0	0
31 Male	1	0	0	0	1	1	1
	24	0	0	0	1	0	0
	48	0	0	0	0	0	0
	72	0	0	0	0	0	0

Table 2: Mean (24, 48 and 72 hours) value eye irritation scores

Animal	Corneal opacity	Iris	Conjunctivae
			Redness	Chemosis
126 Male	0	0	0.7	0
30 Male	0	0	0.3	0
31 Male	0	0	0.3	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not eye irritating

Conclusions:

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

Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted TMPTMA in their right eye (under local anaesthesia) while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded according to the method of Draize (1977).

 

Minimal conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment and in one treated eye at the 48 hour observation. The irritation completely resolved within 72 hours. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 0.3, 0.3 for conjunctivae score and 0, 0, 0 for chemosis score.

 

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