Reaction mass of rel-(2S,4R,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane and rel-(2S,4S,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 - 26 June 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction mass of rel-(2S,4R,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane and rel-(2S,4S,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane

EC Number:

945-924-3

Molecular formula:

C13H18O2

IUPAC Name:

reaction mass of rel-(2S,4R,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane and rel-(2S,4S,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.6 - 2.0 kg
- Housing: individually in PPO cages (floor area: 2576 cm²) with perforated floor
- Diet: Altromin 2123 (Altromin, Lage, Germany), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours
Reading time points: 1, 24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: 20 mL 0.9% sodium chloride solution was used
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

One hour after application of the test material a diffuse, crimson red conjunctiva with individual vessels not easily discernible, obvious swelling with partial eversion of lids and some amount of discharge different from normal were seen in animal No. 1. The remaining three animals showed some conjunctival vessels definitely injected, obvious swelling with partial eversion of lids and some amount of discharge different from normal. After 24 h all animals showed some conjunctival vessels definitely injected and some swelling of the conjunctiva above normal. After 48 h animal No. 1 and 4 showed some conjunctival vessels definitely injected. Animal No. 2 and 3 were free of any signs. After 72 h animal No. 1 and 4 were free of any signs of eye irritation.

Any other information on results incl. tables

Table 1. Results of the eye irritation study

Animal	Time (h)	Conjunctivae		Cornea	Iris
		Redness	Chemosis
1	1	2	2	0	0
	24	1	1	0	0
	48	1	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.67	0.33	0	0
2	1	1	2	0	0
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.33	0.33	0	0
3	1	1	2	0	0
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.33	0.33	0	0
4	1	1	2	0	0
	24	1	1	0	0
	48	1	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.67	0.33	0	0

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.