Perboric acid, sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-04-28 to 1987-05-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium Perborate Monohydrate

IUPAC Name:

Sodium Perborate Monohydrate

Details on test material:

-Physical state: white granules
-Analytical purity: not stated
-Lot/batch No.: not stated
-Storage condition of test material: ambient room temperature and humidity

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Clifford Roedel
-Age at study initiation: no data
-Weight at study initiation: no data
-Housing: 1 per cage
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled
-Humidity (%): controlled

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not required

Amount / concentration applied:

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

VEHICLE
-Amount(s) applied (volume or weight with unit): test item was moistened with a suitable vehicle

Duration of treatment / exposure:

4 hrs

Observation period:

Animals were observed for skin reactions at 30 to 60 min after removal of wrappings and again at 24, 48 and 72 hrs

Number of animals:

3

Details on study design:

TEST SITE
-Area of exposure: 6 cm
-Type of wrap: semi-adhesive dressing which was secured with non-irritating tape

REMOVAL OF TEST SUBSTANCE
-Washing: yes
-Time after start of exposure: 4 hrs

SCORING SYSTEM
according to Draize

The general health of the animals was monitored at each observation time.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2 and 3

Time point:

other: 0.5 - 1 h; 24, 48 and 72 hrs

Score:

1 - 2

Max. score:

2

Reversibility:

fully reversible within: 72 hrs (2 animals)

Remarks on result:

other: for details see table below

Results 2

Irritation parameter:

edema score

Basis:

animal: 1, 2 and 3

Time point:

other: 0.5 - 1 h; 24, 48 and 72 hrs

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 48 hrs (2 animals)

Remarks on result:

other: for details see table below

Irritant / corrosive response data:

Erythema (slight at 30 min and 24/48 hrs after patch removal) was absent to slight after 72 hrs. Oedema was absent to slight at all observation periods. No corrosive effects noted.

Any other information on results incl. tables

	Animal 1	Animal 2	Animal 3
Erythema / Eschar formation	Score	Score	Score
0.5 - 1 h	2	2	2
24 hrs	2	2	1
48 hrs	1	2	1
72 hrs	1	0	0
Oedema
0.5 - 1 h	1	1	0
24 hrs	1	1	0
48 hrs	0	1	0
72 hrs	0	1	0

 

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Sodium Perborate Monohydrate was mild irritating to the skin of rabbits according to the GHS classification system (Category 3, reversible effects in dermal tissue, Draize score >= 1.5 to < 2.3).

Executive summary:

In a skin irritation/corrosion study according to OECD 404, three rabbits were dosed with Sodium Perborate Monohydrate under semi-occlusive conditions to the intact clipped skin at a dose level of 0.5 g/animal.

After an exposure period of 4 hours, patches were removed and sites washed. Dermal reactions were scored according to Draize at 1, 24, 48 and 72 hours after patch removal.

Erythema, slight at 30 min and 24 and 48 hours, was absent to slight after 72 hours. Oedema was absent to slight at all observation periods.

According to GHS, the test item can be classified as mild irritant (Category 3).