2-ethylhexyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl acetate

EC Number:

203-079-1

EC Name:

2-ethylhexyl acetate

Cas Number:

103-09-3

Molecular formula:

C10H20O2

IUPAC Name:

2-ethylhexyl acetate

Details on test material:

- Name of test material (as cited in study report): 2-Etylhexylacetat
- Physical state: Liquid / colorless-clear
- Analytical purity: 99.1 area%
- Lot/batch No.: TK149 v. 27.12.2002
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility .
- Storage condition of test material: Room temperature
- Other: pH value: ca. 6

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A ., 01540 Vonnas, France; SPF quality
- Age at study initiation: about 8 months
- Weight at study initiation: 4.04 - 4.38 kg
- Housing: single in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- 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 the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the liquid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.


SCORING SYSTEM: OECD/ Draize scheme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: see table for details

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Any other information on results incl. tables

Exposition:	24 h
Animal	Reading	Opacity	Cornea area	Iritis	Redness	Chemosis	Discharge	Symptoms
1	1 h	0	0	0	2	0	0	Scleral vessels injected, circumscribed area
2	1 h	0	0	0	2	0	1
3	1 h	0	0	0	2	0	1
1	24 h	0	0	0	1	0	0
2	24 h	0	0	0	2	0	0
3	24 h	0	0	0	1	0	0
1	48 h	0	0	0	0	0	0
2	48 h	0	0	0	1	0	0
3	48 h	0	0	0	1	0	0
1	72 h	0	0	0	0	0	0
2	72 h	0	0	0	0	0	0
3	72 h	0	0	0	0	0	0
1	24 - 72 h	0.00		0.00	0.33	0.00
2	24 - 72 h	0.00		0.00	1.00	0.00
3	24 - 72 h	0.00		0.00	0.67	0.00
mean	24 - 72 h	0.00		0.00	0.67	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Classification: not irritating