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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
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
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).