2-Propenoic acid, 2-propylheptyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-01-11 to 2008-02-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to OECD TG No. 405 and in compliance with GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-propylheptyl acrylate

EC Number:

604-669-5

Cas Number:

149021-58-9

Molecular formula:

C13 H24 O2

IUPAC Name:

2-propylheptyl acrylate

Test material form:

other: liquid

Details on test material:

- Name of test material: 2-Propylheptylacrylat rein
- Test substance number: 07/0846-1
- Analytical purity: 98.5 area-%
- Isomers composition: about 87 % 2 Propylheptylacrylate and 10 % 4-methyl-2-propylhexylacrylate
- Analytical report no.: 07L00384
- Lot/batch No.: B4112/13 - 03122007
- Expiration date of the lot/batch: 2008-12-03
- pH-value: Ca. 5.5 (undiluted test substance)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rabbits / New Zealand white A 1077 INRA (SPF) from Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 5 – 6 months
- Weight at study initiation: 3.52 kg – 4.03 kg
- Housing: Stainless steel wire mesh cages with grating, floor area: 3000 cm². Single housing.
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye of the animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted

Duration of treatment / exposure:

Exposure for 24 h.

Observation period (in vivo):

72 h (the study was discontinued since all animals were without findings 48 h after test start)

Number of animals or in vitro replicates:

3 animals (2 female, 1 male)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system according to OECD Tg 405

TOOL USED TO ASSESS SCORE:
-Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)

Readings:
Approx. 1, 24, 48 and 72 h after application.
Mortality check:
A check for any dead or moribund animal was made twice each workday (at the beginning and end of work) and once daily at weekends and on public holidays.
Evaluation/Scoring:
The evaluation is based on the criteria of the Commission Directive 67/548/EEC and the OECD Harmonized Integrated Classification System that were in place on the date of report signature.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Moderate conjunctival redness (grade 2) was noted in all animals 1 hour after application and decreased to slight (grade 1) in one animal until the 24-hour reading. Moderate or severe discharge (grade 2 or 3) was noted in all animals 1 hour after application, only. In addition injected scleral vessels ina circumscribed area or circular were noted during the observation period.
The ocular reactions were reversible in two animals within 24 hours and in one animal within 48 hours after application.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0 for corneal opacity and for iris lesions, 0.0, 0.0 and 0.3 for redness of the conjunctiva and 0.0 for chemosis. (see details in table 1)

Any other information on results incl. tables

Table 1: Individual ocular examinations and mean values.

Readings	Animals	Cornea		Iris	Conjunctiva			Additional findings
		Opacity	Area of cornea involved		Redness	Chemosis	Discharge
1 h	1	0	0	0	2	0	0	scleral vessels injected, circumscribed area
	2	0	0	0	2	0	0
	3	0	0	0	2	0	0	scleral vessels injected, circular
24 h	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
	3	0	0	0	1	0	0	scleral vessels injected, circumscribed area
48 h	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
	3	0	0	0	0	0	0
72 h	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
	3	0	0	0	0	0	0
Mean 24-72 h	1	0.0		0.0	0.0	0.0	0.0
	2	0.0		0.0	0.0	0.0	0.0
	3	0.0		0.0	0.3	0.0	0.0
Mean		0.0		0.0	0.1	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU