Potassium hexadecyl hydrogen phosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-03-22 until 2005-04-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hexadecyl hydrogen phosphate

EC Number:

242-768-1

EC Name:

Potassium hexadecyl hydrogen phosphate

Cas Number:

19035-79-1

Molecular formula:

C16H35O4P.K

IUPAC Name:

potassium hexadecyl hydrogen phosphate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 3.44 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V2333) ad libitum and hay (approximately 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours light / dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Single dose of 100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after administration of the Test item. Since effects were still present in the eye after 72 hours, further estimations were carried out after 7 and 14 days.

Number of animals or in vitro replicates:

1 animal

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: isotonic saline
- Time after start of exposure: 24 hours after administration

SCORING SYSTEM: As indicated in the guideline

TOOL USED TO ASSESS SCORE: fluorescein-sodium solution

- An initial test was performed using one animal. As the test item showed potential risk of serious damage to eyes only one animal was used in the study
- About 24 hours before the start of the study both eyes of the animal was examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.66

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Any other information on results incl. tables

The conjunctiva of the animal showed 1 hour up to the end of the study (14 days after administration) some diffuse beefy red color and obvious swelling with partial eversion of lids up to swelling with about half closed lids. The cornea showed scattered areas from day 2 up to the end of the study; up to 50 % or slightly more of the cornea was affected. In addition to these observations, the animal showed also colorless serious eye discharge one up to 24 hours after administration. Thereafter up to the end of the study the animal showed white mucous eye discharge. The animal showed additionally vascularization of the cornea from day 8 (slight) up to day 15 (extreme) of the study which indicates irreversible effects. On day 15 the animal was therefore killed for animal welfare reasons.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Testing of the test substance for primary eye irritation in the rabbit showed that the test item caused severe ocular lesions (risk of serious damage to eyes).

Executive summary:

In an eye irritation study according to OECD guideline 405, an amount of 100 mg of the test substance was administered once to the conjunctival sack of the left eye of one female New Zealand White rabbit. The treated eye was washed out 24 hours after the administration of the test item. The untreated eye served as a control.

The test item caused irritating effects in the eye of the animal up to 14 days (end of study) after administration. Extreme cornea vascularization was observed on day 15 indicating irreversible effects and the animal had to be killed for animal welfare reasons. No clinical signs of systemic toxicity were observed.

Summarizing, testing for primary eye irritation in the rabbit showed that the test substance caused severe ocular lesions (risk of serious damage to eyes).