Dialkyl C18 and C18-unsaturated phosphonates

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1967

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:

1967

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In accordance to Section 191.12 (a) (1) and (2) of the Final Orders, Enforcement Regulations, Federal Register, Vol. 29, No. 182, P 13009, 17 September 1964.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dialkyl C18 and C18-unsaturated phosphonates

EC Number:

701-298-1

Cas Number:

64051-29-2

Molecular formula:

Not applicable for a UVCB Substance

IUPAC Name:

Dialkyl C18 and C18-unsaturated phosphonates

Test material form:

liquid

Specific details on test material used for the study:

No data available.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Amount applied: 0.1 ml

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
no data

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: see table of results

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.05

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: see table of results

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: see table of results

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: see table of results

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0	1/0/0/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0	0.05	0
Reversibility*)	-	-	c	-

 

*) Reversibility: c. = completely reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, the mean scores (24, 48 and 72 hours) for six rabbits were 0.0, 0.0, 0.0 and 0.05 for chemosis, iris, corneal opacity and conjunctiva respectively. Therefore, Alkenyl phosphonate is not considered as irritating to eyes according to EU criteria.

Executive summary:

In an eye irritation study (Kr.2, Not GLP), 0.1 mL of Alkenyl phosphonate was instilled into the conjunctival sac of the eye of six Albino New-Zealand White rabbits (6). Animals were then observed for 3 days. Ocular irritation was scored by the method of Draize.

The mean scores (24, 48 and 72 hours) for all tested rabbits were 0.0, 0.0, 0.0 and 0.05 for chemosis, iris, corneal opacity and conjunctiva respectively. Therefore, Alkenyl phosphonate is not considered as irritating to eyes according to EU criteria.