Decyl dihydrogen phosphate, potassium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reported study with only very basic data given; comparable to guideline/standard

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA, Federal Register (17 Sep 1964, 191.12)

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Decyl dihydrogen phosphate, potassium salt

EC Number:

270-390-7

EC Name:

Decyl dihydrogen phosphate, potassium salt

Cas Number:

68427-32-7

Molecular formula:

C10H23O4P.xK

IUPAC Name:

potassium decyl hydrogen phosphate

Details on test material:

Name of test compound: TL 522, 45% a.s.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no info
- Age at study initiation: no info
- Weight at study initiation: no info
- Housing: no info
- Diet (e.g. ad libitum): no info
- Water (e.g. ad libitum): no info
- Acclimation period: no info


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: October 1974

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

VEHICLE: not used

Duration of treatment / exposure:

single application

Observation period (in vivo):

24, 48 and 72 h, day 4, day 7 and in one animal also on days 14 and 21

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
CORNEA
Degree of Opacity (most dense area used)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible 4

IRIS
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection
(any or all of these or combination of any thereof), iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, indiviual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: days 2/3/4

Score:

1.44

Max. score:

4

Reversibility:

not fully reversible within: 21 days (1/3 animals)

Remarks on result:

other: 2/3 animals sacrificed on day 7 because of the severity of the response

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: days 2/3/4

Score:

0.78

Max. score:

2

Reversibility:

fully reversible within: 4 days (1/3 animals)

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: days 2/3/4

Score:

2.11

Max. score:

3

Reversibility:

not fully reversible within: 21 days (1/3 animals)

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: days 2/3/4

Score:

2.56

Max. score:

4

Reversibility:

fully reversible within: 21 days (1/3 animals)

Irritant / corrosive response data:

Cornal opacities developed in all three animals, and an opacity was still present in one animal on day 21. The remaining two animals were sacrificed on day 7 due to the severity of the response. lritis was observed in all three animals. A diffuse crimson to beefy
red colouration of the conjuntivae and considerable swelling with the eyelids about half closed was observed in all three animals.

Other effects:

Not reported.

Any other information on results incl. tables

Summary of ocular lesions

Anim. No.	Effect	Days after application							Mean score cornea Days 2/3/4*	Mean score iritis Days 2/3/4*	Mean score redness Days 2/3/4*	Mean score chemosis Days 2/3/4*
		1	2	3	4	7	14	21
1	Cornea* Iris Redness Chemosis	1 1 2 2	1 1 2 2	1 1 2 3	2 0 2 2	4 0 1 1	3 0 1 1	2 0 1 0	1.33	0.67	2	2.33
2	Cornea* Iris Redness Chemosis	1 0 2 2	1 0 2 2	1 1 3 3	4 1 2 3	4 1 2 3	nm	nm	2	0.67	2.33	2.67
3	Cornea* Iris Redness Chemosis	1 0 1 2	1 1 2 2	1 1 2 3	1 1 2 3	4 1 2 3	nm	nm	1	1	2	2.67
Mean all anim.									1.44	0.78	2.11	2.56

nm = not measured as animals had been sacrificed; * score on days 2/3/4 was averaged as signs were generally more severe on day 4 than on day 1   

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

As the changes in the eye were not reversible within 21 days in one animal, and the other 2 animals were sacrificed on day 7 because of the severity of the response, the test compound was considered a serious irritant to the rabbit eye.

Executive summary:

A study was performed to assess the irritancy potential of the test material consisting of 45% decylphosphoric acid, potassium salt (CAS 68427-32-7) to the eye of the rabbit (strain not specified). A single application of the test material to the eye of three rabbits produced serious irritation. The treated eye of one animal was still not normal 21 days after application; the other 2 animals were sacrificed on day 7 due to the severity of the response. The test material requires classification in Category 1 according to OECD-GHS.