Reaction mass of geranyl acetate and neryl 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: according to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neryl acetate

EC Number:

205-459-2

EC Name:

Neryl acetate

Cas Number:

141-12-8

Molecular formula:

C12H20O2

IUPAC Name:

3,7-dimethylocta-2,6-dien-1-yl acetate (Z)-

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Nerylacetat
- Lot/batch No.: 50547891
- Physical state: colourless liquid
- Analytical purity: 94.2 %
- Storage condition of test material: cool and dry

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino - Chbb:HM(SPF) Littlerussian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet "Altromin 2123" was available, ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least 1 w


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 40 - 60
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

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

Duration of treatment / exposure:

single treatment (washed out after 24h)

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM:
according to OECD guideline
TOOL USED TO ASSESS SCORE: fluorescein after 24 h

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal 1-4

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal 1-4

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal 1-4

Time point:

other: 24, 48, 72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal 1-4

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 72h

Any other information on results incl. tables

		Cornea	Iris	Conjunctiva
Readings	Animal	Opacity		Redness	Swelling
1h	1	0	1	1	1
	2	0	0	1	0
	3	0	0	1	1
	4	0	0	1	1
24h	1	0	0	1	0
	2	0	0	1	1
	3	0	0	1	1
	4	0	0	1	1
48h	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
	4	0	0	1	1
72d	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
	4	0	0	0	0
Mean (24h-72h)	1	0,0	0,0	0,3	0,0
	2	0,0	0,0	0,3	0,3
	3	0,0	0,0	0,3	0,3
	4	0,0	0,0	0,7	0,7
Mean (24h-72h)	all animals	0,0	0,0	0,4	0,3