Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
01 April - 15 July 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Full read-across justification report is attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Anhydrous Sodium Perchlorate
- Physical state: white powder
- Analytical purity: 98.21%
- Purity test date: 10/01/2008
- Lot/batch No.: GRL 0005/08
- Expiration date of the lot/batch: February 2010
- Storage condition of test material: At room temperature, keep hermatically closed.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Grimaud Freres Selection S.A.S., La Corbiere, Roussay, France
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.7 ± 0.3 kg
- Housing: individually in Pajon cages (50x57x75cm)
- Diet: 110C pelleted ad libitum (SAFE, Augy, France)
- Water: Filtered - FG millipore (0.22µm) ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: (30 -70%):
- Air changes: 12 cycles per hr of filtered non-recycled air
- Photoperiod: 12hrs dark /12 hrs light (7:00-19:00)


IN-LIFE DATES: From: 01 April 2008 To: 06 April 2008

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amounts applied: 500mg in its original form placed on a gauze pad moistened with purified water



Duration of treatment / exposure:
up to 4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 square cms
- % coverage: 100%
- Type of wrap if used: Gauze pad held by means of an hypoallergenic aerated semi-occlusive dressing and a restraining bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After 4 hours, residual test item was wiped off by means of a dry or moistened cotton pad.


SCORING SYSTEM:
Erythema and eschar formation:
0: no erythema
1: very slight erythema (barely perceptible)
2: well defined erythema
3: moderate to severe erythema
4: severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema formation:
0: no edema
1: very slight edema (barely perceptible)
2: slight edema (edges of area well-defined by definite raising)
3: moderate edema (raised approx. 1mm)
4: severe edema (raised more than 1mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
After a 3-minute exposure (one animal), no cutaneous reactions were observed. After a 1-hour exposure (one animal) a very slight erythema was
noted from day 1 until day 3. After a 4-hour exposure (three animals) a very slight erythema was noted in all animals on day 1; it persisted on day 2
in one of them. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.

Any other information on results incl. tables

After a 3-minute exposure (one animal) no cutaneous reactions were observed (Table1).

After a 1-hour exposure (one animal) a very slight erythema was noted from day 1 until day 3 (Table 2).

After a 4-hour exposure (three animals) a very slight erythema was noted in all animals on day 1; it persisted on day 2 in one of them. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema (Table 3).

Table 1: Three minute exposure - Cutaneous examinations and mean values of the

scores recorded for the first animal (24, 48 and 72 hours) 

Rabbit No.

Dermal Irritation

Scores

Mean irritation score (1)

1 hour

Day 1

24 hours

Day 2

48 hours

Day 3

72 hours

Day 4

62

Erythema

0

0

0

0

0.0

Edema

0

0

0

0

0.0

Other

*

*

*

*

 

(1): mean of scores on days 2, 3 & 4

*: none

Table 2: One hour exposure - Cutaneous examinations and mean values of the scores recorded

for the first animal (24, 48 and 72 hours)

Rabbit No.

Dermal Irritation

Scores

Mean irritation score (1)

1 hour

Day 1

24 hours

Day 2

48 hours

Day 3

72 hours

Day 4

62

Erythema

1

1

1

0

0.7

Edema

0

0

0

0

0.0

Other

*

*

*

*

 

(1): mean of scores on days 2, 3 & 4

*: none

Table 3: Four hour exposure - Individual cutaneous examinations and mean values of the scores recorded

for each animal (24, 48 and 72 hours)

Rabbit No.

Dermal Irritation

Scores

Mean irritation score (1)

Interpretation

(+)

(-)

1 hour

Day 1

24 hours

Day 2

48 hours

Day 3

72 hours

Day 4

62

Erythema

1

1

0

0

0.3

(-)

Edema

0

0

0

0

0.0

(-)

Other

*

*

*

*

 

 

 

73

Erythema

1

0

0

0

0.0

(-)

Edema

0

0

0

0

0.0

(-)

Other

*

*

*

*

 

 

 

74

Erythema

1

0

0

0

0.0

(-)

Edema

0

0

0

0

0.0

(-)

Other

*

*

*

*

 

 

(1): mean of scores on days 2, 3 and 4

(+): irritant according to EEC criteria

(-): non-irritant according to EEC criteria

*: none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation (EC) No 1972/2008 on CLP
Conclusions:
Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was
slightly irritant when applied topically to rabbits. However, according to the classification criteria laid down in Council Directive 67/548/EEC
(and subsequent adaptations), the test item was considered non-irritant.
Executive summary:

The potential of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 24th April 2002) and EC (2004/73/EC, B.4, 29th April 2004) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was slightly irritant when applied topically to rabbits. However, according to the classification criteria laid down in Council Directive 67/548/EEC and EU regulation (EC) No 1272/2008 (CLP), the test item was considered non-irritant.