Dimethyl octadecylphosphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

72 hours

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

A volume of the test item (equivalent to 0.1 mL) was placed in the conjunctival sac of one eye in 6 New Zealand Albino Rabbits (6 ♀, approximately 9 weeks old) and the lid was held together briefly.

The ocular reactions of the cornea, iris, and conjunctiva were graded at 1, 2 and 3 days after dosing by the Draize scoring system. In addition, eyes were examined on day three using sodium fluorescein.

GLP compliance:

yes

Remarks:

FDA's GLP

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl octadecylphosphonate

EC Number:

246-904-0

EC Name:

Dimethyl octadecylphosphonate

Cas Number:

25371-54-4

Molecular formula:

C20H43O3P

IUPAC Name:

dimethyl octadecylphosphonate

Constituent 2

Reference substance name:

M-5925

IUPAC Name:

M-5925

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test Identification: M-5925
Description: White powder
Purity: Not reported

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Nicholas Helf
- Age at study initiation: 9 weeks
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Individually housed in suspended wire mesh cages
- Diet (e.g. ad libitum): Rabbits were fed Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approx. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified (in accordance with the standards of AAALAC)
- Humidity (%): not specified (in accordance with the standards of AAALAC)
- Air changes (per hr): not specified (in accordance with the standards of AAALAC)
- Photoperiod (hrs dark / hrs light): not specified (in accordance with the standards of AAALAC)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye acts as a control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

72h (the test item was not flushed from the eye after dosing)

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

6 ♀, approximately 9 weeks old.

Details on study design:

The test item equivalent to 0.1 mL was placed in the conjunctival sac of one eye in 6 New Zealand Albino Rabbits (6 ♀, approximately 9 weeks old) and the lid was held together briefly.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: not applicable

SCORING SYSTEM: The ocular reactions of the cornea, iris, and conjunctiva were graded at 1, 2 and 3 days after dosing according to the method by Draize.

TOOL USED TO ASSESS SCORE: In addition, eyes were examined on day three using sodium fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72 h

Score:

0.06

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: Mean of 24, 48 and 72 h

Score:

1.39

Max. score:

3

Reversibility:

not specified

Remarks:

last evaluation was at 72 hr

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 h

Score:

0.89

Max. score:

4

Reversibility:

not specified

Remarks:

last evaluation was at 72 hr

Irritant / corrosive response data:

Based on the following mean scores for 24, 48 & 72 hours: Corneal opacity - 0, Iridial inflammation - 0.06, Conjunctival redness - 1.39,
Conjunctival chemosis - 0.89, the test item is not classified for irritation according to the criteria in Regulation (EC) 1272/2008.

Other effects:

UV Fluorescein scan at 3 days was scored 0 in all animals.

Any other information on results incl. tables

Individual and mean scores for cornea, iris & conjunctivae for EC labelling regulations

Animal number	Time after treatment	Corneal opacity	Iridial inflammation	Conjunctival redness	Conjunctival chemosis
5001	24 hr	0	0	2	1
	48 hr	0	0	1	1
	72 hr	0	0	1	0
Total		0	0	4	2
Mean		0	0	1.33	0.67
5002	24 hr	0	1	2	2
	48 hr	0	0	2	2
	72 hr	0	0	1	2
Total		0	1	5	6
Mean		0	0.33	1.67	2.00
4352	24 hr	0	0	2	1
	48 hr	0	0	1	1
	72 hr	0	0	1	0
Total		0	0	4	2
Mean		0	0	1.33	0.67
5006	24 hr	0	0	2	1
	48 hr	0	0	1	1
	72 hr	0	0	1	1
Total		0	0	4	1
Mean		0	0	1.33	0.67
5007	24 hr	0	0	2	1
	48 hr	0	0	1	1
	72 hr	0	0	1	1
Total		0	0	4	3
Mean		0	0	1.33	0.67
5008	24 hr	0	0	2	1
	48 hr	0	0	1	1
	72 hr	0	0	1	1
Total		0	0	4	3
Mean		0	0	1.33	0.67
Group mean		0	0.06	1.39	0.89

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to Regulation EC 1272/2008, dimethyl octadecylphosphonate is not classified as irritating to eyes.

Executive summary:

The test item (equivalent to 0.1 mL) was placed in the conjunctival sac of one eye in 6 New Zealand Albino Rabbits (6 ♀, approximately 9 weeks old) and the lid was held together briefly. The ocular reactions of the cornea, iris, and conjunctiva were graded at 1, 2 and 3 days after dosing according to the grading system of Draize. In addition, eyes were examined on day three using sodium fluorescein.

Based on the following mean scores for all animals for 24, 48 & 72 hours: Corneal opacity - 0, Iridial inflammation - 0.06, Conjunctival redness - 1.39 and Conjunctival chemosis - 0.89, dimethyl octadecylphosphonate is not classified for irritation to the eye according to the criteria in Regulation (EC) 1272/2008.