1-Butanone, 3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-, rel-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 02 June 2004 to 11 June 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to OECD test guideline No. 405 and in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Compliance Programme (inspected on 2002-12-02)

Test material

Test material information

Constituent 1

Reference substance name:

(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Constituent 2

Reference substance name:

(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Constituent 3

Reference substance name:

(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Constituent 4

Reference substance name:

(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Test material form:

liquid

Details on test material:

- Physical state: white solid or Colourless liquid (depending on temperature)

Specific details on test material used for the study:

- Storage condition of test material: ca. 4°C in the dark under nitrogen

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, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access (Certified Rabbit Diet (Code 5322) supplied by BCM IPS Limited, London, UK)
- Water (e.g. ad libitum): free access
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 02 June 2004 To: 11 June 2004

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye (untreated eye)

Amount / concentration applied:

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

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1 hour and 24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: N.A.

SCORING SYSTEM: Draize scale, as described in OECD Test Guideline 405.

TOOL USED TO ASSESS SCORE: light source from a standard ophtalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

chemosis score

Basis:

animal: # 1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal: # 1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal: # 1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24 and 48-hour observations. All treated eyes appeared normal at the 72-hour observation.

Other effects:

none

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data each animals at each observation time up to removal from the test

 

Score at time point / Reversibility	Cornea		Iris (/2)	Conjunctivae
	Opacity (/4)	Area (/4)		Redness (/3)	Chemosis (/4)	Discharge (/3)
1 h	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0	1 / 1 / 2	1 / 1 / 1	1 / 1 / 2
24 h	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0	1 / 1 / 1	0 / 0 / 1	0 / 0 / 1
48 h	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0	1 / 1 / 1	0 / 0 / 1	0 / 0 / 1
72 h	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0
Average 24h, 48h, 72h	0 / 0 / 0	0 / 0 / 0	0 / 0 / 0	0.7 / 0.7 / 0.7	0 / 0 / 0.7	0 / 0 / 0.7
Reversibility*)	-	-	-	c.	c.	c.
Average time (unit) for reversion	-	-	-	72 h	72 h	72 h

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and according the GHS.

Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 3 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item. The left eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale. 

Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment.

All treated eyes appeared normal at the 72-hour observation.

The calculated mean score for each individual lesion for each animals within 3 scoring times (24, 48 and 72 h) were 0.7/0.7/0.7 for redness, 0.0/0.0/0.7 for chemosis and 0.0/0.0/0.0 for discharge, iris and corneal lesions.

 

Under the test conditions, the test material is not classified as irritating to eyes according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.