Dibutyl phosphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 14 June to 29 May, 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: section 191.12 of the final order, Enforcement Regulation, Federal regulation vol. 29 September 1964

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

some parameters not specified in study report (exact species, washing performed, vehicle used)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl phosphonate

EC Number:

217-316-1

EC Name:

Dibutyl phosphonate

Cas Number:

1809-19-4

Molecular formula:

C8H19O3P

IUPAC Name:

dibutyl phosphonate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Test system

Vehicle:

not specified

Controls:

not specified

Duration of treatment / exposure:

No data

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks:

not reversible in 1/3 animals

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

iris score

Basis:

animal: #2 & #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1 & #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Any other information on results incl. tables

Table: Eye irritation results.

		Day 1	Day 2	Day 3	Day 4	Day 7
Animal 1	Corneal opacity	1	1	1	1	1
	Iritis	1	1	1	0	0
	Conjunctival redness	2	1	1	1	0
	Conjunctival chemosis	2	1	1	0	0
Animal 2	Corneal opacity	1	1	1	1	0
	Iritis	1	1	0	0	0
	Conjunctival redness	2	1	1	1	0
	Conjunctival chemosis	2	1	1	0	0
Animal 3	Corneal opacity	1	1	1	1	0
	Iritis	1	1	0	0	0
	Conjunctival redness	2	1	1	0	0
	Conjunctival chemosis	2	1	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (Eye irritant) based on CLP Regulation (EC no. 1272/2008)

Conclusions:

Irritating to the rabbit eye

Executive summary:

The eye irritation potential of the substance was evaluated in an experimental study performed according to the criteria specified in paragraph 191.12 of the final Order, Enforcement regulations, federeal regulation, federal registror vol. 29, N 192, P.13009, 17 september 1964, a method similar to the OECD Guideline 405. The test item was applied directly into the the eye of three albino rabbits and the site was monitored for corneal opacity, iritis, conjunctival redness and chemosis according to Draize scores, immediately after application and then at 1, 2, 3 and 7 days after application.

Corneal opacity scores were 1.0 in all animals at all time points, with the exception of the 7 day reading, which was 0.0 in two out of the three animals. Iritis scores were 1.0 in all animals both immediately after application and after 1 day; 2 days after application, the iritis scores were 0.0 for two animals and 1.0 for one animal, after which time the iritis scores were 0.0 for all animals until end of study period. Conjunctival redness scores were 2.0 in all animals immediately after application; 1.0 in all animals after both 1 and 2 days; 0.0 (1 animal) and 1.0 (2 animals) after 3 days, and 0.0 among all animals after 7 days. Conjunctival chemosis scores were 2.0 among all animals immediately after application; 1.0 among all animals after 1 day; and 1.0 (2 animals) and 0.0 (1 animal) after 2 days; all animals had scores of 0.0 after 3 and 7 days.

The mean (24/48/72 hour) scores for the four parameters examined can be interpreted for each animal as follows: corneal opacity = 1.0 (all animals); iritis = 0.33 and 0.67 (2 and 1 animals, respectively); conjunctival redness = 0.67 and 1.0 (1 and 2 animals, respectively); chemosis = 0.33 and 0.67 (1 and 2 animals, respectively).

It is apparent that the test item is irritating to the rabbit eye, however, it should be noted that all parameters were reversible within a 7-day window with the exception of a corneal opacity score of 1.0 in one rabbit only after 7 days.