H112323

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted equivalent or similar to EU Method B.4. and OECD Guideline 404 in compliance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): H112323
- Physical state: Dark blue powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK
- Age at study initiation: 15-24 wk
- Weight at study initiation: 3081-4125 g
- Housing: Housed individually in anodised aluminium sheet cages
- Diet (e.g. ad libitum): Labsure CRB Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance pasted with small amount of deion. water

Duration of treatment / exposure:

4 h

Observation period:

30-60 min, 24, 48 and 72 h after removal of the patches, additional readings were performed after 7 d

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: Left flank
- % coverage: 2.5 x2.5 cm
- Type of wrap if used: Yes, The treated areas were covered with pieces of surgical gauze (approximate size 2.5 cm x 2.5cm; 8 ply) each of which was secured by two crossed strips of surgical tape (approximate size 1cm x 8cm). These were covered by a piece of impermeable rubber sheeting (approximate size 35cm x 13cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape (7.5cm wide).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently cleansed free of any residual test sample using clean swabs of absorbent cotton wool soaked in clean warm water and were then dried gently with clean tissue paper.
- Time after start of exposure: 4 h

SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the DRAIZE scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no erythema observed

Remarks on result:

other: -

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema observed

Remarks on result:

other: -

Irritant / corrosive response data:

- There were no signs of erythema in any animal.
- Very slight oedema was seen in two animals 30-60 min after decontamination. There were no additional signs of irritation.

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test substance was considered to be non-irritant to rabbit skin following a single 4-h application.

Executive summary:

A study was conducted to assess the skin irritation potential of test substance to the rabbit skin equivalent or similar to OECD Guideline 404 and EU Method B.4.

A group of three male rabbits each received a single four-hour application of test sample to the shorn flank. The animals were assessed for any signs of skin irritation 30-60 minutes after decontamination and then daily for 3 days.

Very slight oedema was observed in two animals 30-60 minutes after decontamination. There were no further signs of irritation. In conclusion, Substance H112323 was non-irritant to rabbit skin following a single four-hour application.