3,7-dimethylocta-2,6-dienyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 March 2000 - 18 March 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The in vivo test was performed before the REACH regulation came into force, requesting in vitro studies. This information is used for read-across to Neryl acetate multi

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)

Version / remarks:

February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

January 1997

Deviations:

no

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:

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

Test animals / tissue source

Species:

rabbit

Strain:

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

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Age at study initiation: Young adult animals
- Weight at study initiation: females 2.5-2.9 kg bodyweight
- Housing: Housed individually in in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: Available ad libtum pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe,
- Water: Free acces domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

4

Details on study design:

Study design
0.1 mL of the test item was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The lids were then gently held together for 1 second.
The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution the eyes were examined again using UV-light to detect possible comeal damage. The eyes were also examined 48 and 72 hours after the treatment.

Scoring: according to guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 15

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 16

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

One hour after application of the test article one rabbit showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light.
In addition, in all rabbits a conjunctiva with injected vessels and swelling and/or discharge was observed.
All eye irritation effects were fully reversible within 72 hours.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant.

Remarks:

according to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

Slight signs of irritation were observed on the treated eyes (mean values for redness and oedema of conjunctive of 0.33-0.67). All effects were fully reversible within 72 hours. Based on these data it is concluded that Neryl Acetate (‘mono’) is not corrosive and not irritant to the eye.

Executive summary:

For Neryl Acetate (‘mono’) an in vivo skin irritation study is available according to OECD TG 405 and in compliance with GLP criteria. In this study, 4 female albino rabbits were exposed to 0.1 ml of the test item in the left eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing. Slight signs of irritation were observed on the treated eyes (mean values for redness and oedema of conjunctive of 0.33-0.67). All effects were fully reversible within 72 hours. Based on these data it is concluded that Neryl Acetate (‘mono’) is not corrosive and not irritant to the eye.