1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 July 1993 - 9 July 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether

EC Number:

293-883-9

EC Name:

1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether

Cas Number:

91648-24-7

Molecular formula:

C14H24O4

IUPAC Name:

2,2-bis(hydroxymethyl)propane-1,3-diol; 3-(prop-2-en-1-yloxy)prop-1-ene

Test material form:

liquid

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, Chesire, U.K.
- Age at study initiation: 12 - 16 weeks old
- Weight at study initiation: 2.44 - 2.58 kg
- Housing:Suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20- 23 °C
- Humidity: 59- 65 %
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark /12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.1 mL

Duration of treatment / exposure:

Not applicable, the eyes were not rinsed after the instillation of the test item

Observation period (in vivo):

1, 24,48 and 72 hours after treatment

Number of animals or in vitro replicates:

3 animals

Details on study design:

- 0.1 mL of test substance was instilled in the right eye of test animals
- Washing: The eyes were not rinsed after application of the test material

SCORING SYSTEM:Draize scale, according to OECD TG 405

TOOL USED TO ASSESS SCORE: Light source from a standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Minimal conjunctival redness was noted in all treated eyes 1hr after treatment but all eyes appeared normal at the 24-hr observation.

Other effects:

Residual test material was noted around the treated eye of all animals 1 hr after treatment

Any other information on results incl. tables

Scores for irritation

Animal No. /Sex	Region of the eye		Hours (h) after treatment				Mean^a
			1h	24h	48h	72h
101/ F	Cornea	Opacity	0	0	0	0	0
		Area involved	0	0	0	0
	Iris		0	0	0	0	0
	Conjuctiva	Redness	1	0	0	0	0 0
		Chemosis	0	0	0	0
		Discharge	0^b	0	0	0
34/ M*	Cornea	Opacity	0	0	0	0	0
		Area involved	0	0	0	0
	Iris		0	0	0	0	0
	Conjuctiva	Redness	1	0	0	0	0 0
		Chemosis	0	0	0	0
		Discharge	0^b	0	0	0
97/ F*	Cornea	Opacity	0	0	0	0	0
		Area involved	0	0	0	0
	Iris		0	0	0	0	0
	Conjuctiva	Redness	1	0	0	0	0 0
		Chemosis	0	0	0	0
		Discharge	0^b	0	0	0

a Mean of 24, 48 and 72 hour readings

b Residual test material around treated eye

*One drop of ophthaine was instilled into each eye 1-2 minutes before dosing

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether induced no significant eye irritation to test animals. The test substance is not classified as irritating to the eyes according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP)

Executive summary:

In an eye irritation study performed according to OECD guideline 405 and in compliance with GLP, 0.1 mL of undiluted test material 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether was instilled into the right eye of three New Zealand White Rabbits. The eyes were not rinsed after the instillation of the test item. The left eye remained untreated and served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing. 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. No corneal or iridial effects were noted during the study. Residual test material was noted around the treated eye of all animals 1 hour after treatment. Additionally, minimal conjunctival redness was noted in all treated eyes 1 hour after treatment but all eyes appeared normal at the 24-hour observation. The calculated mean scores for redness, discharge, chemosis, iris and corneal lesions for all animals at 24, 48 and 72h after treatments were 0. Based on the results of this study, 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is not classified for eye irritation according to the CLP Regulation.