myo-inositol-hexakisphosphate 3-phosphohydrolase

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 October 1999 - 29 October 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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, England
- Age at study initiation: 8 weeks
- Weight at study initiation: 1581-1717 grams
- 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Test item: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 10x15 cm
- % coverage: 5% (2x3 cm)
- Type of wrap if used: Micropore tape, secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS : 1, 24, 48 and 72 hours after removal of the dressings and test substance

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Very slight erythema was observed 1 hour after removal of the test item. This effect was fully reversed after 24 hours.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema in the treated skin-area of one animal was observed 1 hour after exposure, this was fully reversed after 24 hours. No oedema was noted in any of the animals.

Other effects:

- Corrosion: There was no evidence of a corrosive effect on the skin.
- Colouration: No staining of the treated skin 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.
- No histopathology was performed.

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 skin irritation study, performed according to OECD guideline 404 and GLP principles, NPH 54 is not irritating or corrosive to the skin. The test item is not classified for skin irritation according to GHS and Regulation EC No. 1272/2008.