myo-inositol-hexakisphosphate 3-phosphohydrolase

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 November 1999 - 4 November 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Physical appearance: brown liquid
Storage conditions:in a freezer in the dark or, after thawing, in a refrigerator in the dark

Specific details on test material used for the study:

Aseptic conditions were used since the test substance is very sensitive to microbial growth/contamination.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, England
- Age at study initiation: 7 weeks
- Weight at study initiation: 1195-1572 g
- Housing: Individually in cages with perforated floors
- Diet: Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany, approx. 100 grams/day
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Test item: 0.1 mL

Duration of treatment / exposure:

The test item was applied once and was not removed by washing prior to observations.

Observation period (in vivo):

1, 24, 48 and 72 hours after installation of the test item

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: 2% fluorescein was instilled in both eyes immediately after the 24 hour observation. In case standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an aopthalmic examination lamp.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: Redness of the sclera was observed after 1 hour of test item installation. This was fully reversed after 24 hours.

Results 9

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: Redness of the sclera was observed after 1 hour of test item installation. This was fully reversed after 24 hours.

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Installation of 0.1 mL of the test item into on eye of each of the three rabbits resulted in irritation of the conjunctivae, which was seen as redness of the sclera of two animals, 1 hour after instillation only. No further irritation of the conjunctivae was noted and no iridial irritation or corneal opacity were observed. Treatment of the eyes with 2% fluorescein, 24 hours after test item installation, revealed no corneal epithelial damage in any of the animals.

Other effects:

- Corrosion: there was no evidence of ocular corrosion.
- Colouration: no staining of peri-ocular tissues by the test item was observed.
- Toxicity/mortality: no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to EC Regulation No. 1272/2008

Conclusions:

Based on the results of an in vivo eye irritation study, performed according to OECD guideline 405 and GLP principles, NPH 54 is not irritating to the eyes. The test item is not classified according to GHS and Regulation EC No. 1272/2008.