Ammonium perchlorate

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Anydrous Sodium Perchlorate

IUPAC Name:

Anydrous Sodium Perchlorate

Constituent 2

Reference substance name:

Sodium perchlorate

EC Number:

231-511-9

EC Name:

Sodium perchlorate

Cas Number:

7601-89-0

IUPAC Name:

sodium perchlorate

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

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.