Potassium perchlorate

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 April - 15 July 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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)

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

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

No. 74

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

No. 74

Time point:

24/48/72 h

Score:

0

Max. score:

0

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.

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

Interpretation of results:

GHS criteria not met

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.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

01 April - 15 July 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

In water, potassium perchlorate will rapidly dissolve and completely dissociate into the perchlorate anion and the corresponding cation. Toxicity is determined only by the perchlorate moiety of the salt. as potassium is known to be non-toxic. Based on that, read-across is possible to other perchlorate salt dissociating in water without any toxic cation.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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)

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

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

No. 74

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

No. 74

Time point:

24/48/72 h

Score:

0

Max. score:

0

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.

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

Interpretation of results:

GHS criteria not met

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.
Based on the read-across justification potassium perchlorate can be considered as not skin irritating.

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.

Reference 3

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 April - 04 May 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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: 3.0 ± 0.2 kg
- Housing: Individually in Pajon cages (50 x 57 x 75 cm)
- Diet: ad libitum 110C pelleted diet (SAFE, Augy, France).
- Water: ad libitum filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days


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


IN-LIFE DATES: From: 08 April 2008 To: 04 May 2008

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg of the test item in its original form

Duration of treatment / exposure:

One application to one eye and there was no rinsing after administration. The other eye acted as control.

Observation period (in vivo):

up to 12 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
The test material was not removed after exposure


SCORING SYSTEM:

Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
. no swelling ...............................................................................................................................0
. any swelling above normal (includes nictitating membranes) ...................................... ..1
. obvious swelling with partial eversion of lids......................................................................2
. swelling with lids about half-closed......................................................................................3
. swelling with lids more than half-closed .............................................................................4


Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal ...............................................................................................................0
. a number of blood vessels definitely hyperemic (injected).................................................1
. diffuse, crimson colour, individual vessels not easily discernible ....................................2
. diffuse, beefy red........................................................................................................................3

Discharge
. absence of discharge .............................................................................................................. .0
. slight discharge (does not include small amounts normally found in
inner canthus) ..............................................................................................................................1
. discharge with moistening of lids and hairs adjacent to lids...............................................2
. discharge with moistening of lids and hairs on wide area around the eye........................3

Iris lesions
. normal ..........................................................................................................................................0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal
hyperemia, or injection, any of these or combination of any thereof, iris still
reacting to light (sluggish reaction is positive) .......................................................................1
. no reaction to light, haemorrhage, gross destruction (any or all of these) ......................2

Corneal lesions
Degree of opacity (area most dense taken for reading)
. no ulceration or opacity..............................................................................................................0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre),
details of iris clearly visible ..........................................................................................................1
. easily discernible translucent area, details of iris slightly obscured ...................................2
. nacreous areas, no details of iris visible, size of pupil barely discernible ..........................3
. opaque cornea, iris not discernible through the opacity.......................................................4

Area of opacity
. one quarter (or less) but not zero..............................................................................................1
. greater than one quarter but less than a half...........................................................................2
. greater than one half but less than three quarters..................................................................3
. greater than three quarters up to whole area. .........................................................................4

Any other lesions observed were noted.

TOOL USED TO ASSESS SCORE: UV lamp/ 0.5% sodium fluorescein

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

2.4

Max. score:

4

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Remarks:

2 rabbits

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 3-6 days

Irritant / corrosive response data:

Slight to marked chemosis was observed in all animals from day 1 until day 6, 9 or 11.
Slight to severe redness of the conjunctiva was noted in all animals from day 1 until day 6 (one animal) or 11 (two animals).
A clear to whitish purulent discharge was noted in all animals from day 1 until day 3 (two animals) or 4 (one animal).
An iritis was noted in 2/3 animals from day 1 until day 3 or 5 and on day 2 in 1/3 animals.
A slight or moderate corneal opacity was recorded in 2/3 animals on days 2 and 3. In the third animal, a slight to severe corneal opacity, which covered sometimes the whole area of the cornea, was noted from day 1 until day 5.
Brownish area on the third eyelid was observed in 1/3 animals from day 7 until day 11.
Mean scores calculated for each animal over 24, 48 and 72 hours were 2.0, 2.3 and 3.0 for chemosis, 2.3, 2.0 and 2.7 for redness of the conjunctiva, 0.7, 0.3 and 1.0 for iris lesions and 1.0, 1.0 and 2.3 for corneal opacity.

Table 1a: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)

Rabbit Number	Region of Eye	Description of ocular reactions	Scores				Mean irritation score (1)	Interpretation (+) (-)
			1 hour Day 1	24 hours Day 2	48 hours Day 3	72 hours Day 4
62	Conjunctivae	Chemosis	2	2	2	2	2.0	(+)
		Redness	3	3	2	2	2.3	(-)
		Discharge	1	2	1	0	1.0
	Iris		1	1	1	0	0.7	(-)
	Corneal opacity	Intensity	0	2	1	0	1.0	(-)
		Area	0	1	1	0	0.7
	Other		*	*	*	*
	Fluorescein		/	U	U	U
73	Conjunctivae	Chemosis	2	3	2	2	2.3	(+)
		Redness	2	2	2	2	2.0	(-)
		Discharge	2	2	1	0	1.0
	Iris		0	1	0	0	0.3	(-)
	Corneal opacity	Intensity	0	2	1	0	1.0	(-)
		Area	0	1	1	0	0.7
	Other		*	*	*	*
	Fluorescein		/	U	U	U
816	Conjunctivae	Chemosis	2	3	3	3	3.0	(+)
		Redness	2	2	3	3	2.7	(+)
		Discharge	2	S	S	S	(2)
	Iris		1	1	1	1	1.0	(+)
	Corneal opacity	Intensity	2	2	3	2	2.3	(+)
		Area	2	4	4	2	3.3
	Other		Su	*	*	*
	Fluorescein		/	U	U	U

 

(1): mean of scores on days 2, 3 and 4       (2): not calculable

(+): irritant according to EEC criteria           U: fluorescein (batch No. L653 & P756)

(-): non-irritant according to EEC criteria     /: fluorescein not used

S: whitish purulent discharge Su: residual test item

*: none

Table 1b: Individual ocular examinations of the scores recorded for each animal (from Day 5 to Day 12)

Rabbit Number	Region of Eye	Description of ocular reactions	Scores
			Day 5	Day 6	Day7	Day 8	Day 9	Day 10	Day 11	Day 12
62	Conjunctivae	Chemosis	1	1	0	-	-	-	-	-
		Redness	1	1	0	-	-	-	-	-
		Discharge	0	0	0	-	-	-	-	-
	Iris		0	0	0	-	-	-	-	-
	Corneal opacity	Intensity	0	0	0	-	-	-	-	-
		Area	0	0	0	-	-	-	-	-
	Other		*	*	*	-	-	-	-	-
	Fluorescein		/	/	/	-	-	-	-	-
73	Conjunctivae	Chemosis	1	1	1	1	1	1	1	0
		Redness	2	2	2	2	1	1	1	0
		Discharge	0	0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0	0
	Corneal opacity	Intensity	0	0	0	0	0	0	0	0
		Area	0	0	0	0	0	0	0	0
	Other		*	*	*	*	*	*	*	*
	Fluorescein		/	/	/	/	/	/	/	/
816	Conjunctivae	Chemosis	2	1	1	1	1	0	0	0
		Redness	2	2	1	1	1	1	1	0
		Discharge	0	0	0	0	S	S	0	0
	Iris		1	0	0	0	0	0	0	0
	Corneal opacity	Intensity	1	0	0	0	0	0	0	0
		Area	1	0	0	0	0	0	0	0
	Other		*	*	ZB	ZB	ZB	ZB	ZB	*
	Fluorescein		U	U	/	/	/	/	/	/

 *: none                                                                       ZB: brownish area on the third eyelid

U: fluorescein (batch No. P756)                                  -:  ocular examination not performed

/: fluorescein not used

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the experimental conditions of the study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was irritant when administered by the ocular route to rabbits.

Executive summary:

The potential of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th April 2002) and EC (2004/73/EC, B.5, 29th April 2004) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Under the experimental conditions of the study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was irritant when administered by ocular route to rabbits and should be classified as Irritant, Category 2 under CLP (GHS).

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

08 April - 04 May 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

In water, potassium perchlorate will rapidly dissolve and completely dissociate into the perchlorate anion and the corresponding cation. Toxicity is determined only by the perchlorate moiety of the salt. as potassium is known to be non-toxic. Based on that, read-across is possible to other perchlorate salt dissociating in water without any toxic cation.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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: 3.0 ± 0.2 kg
- Housing: Individually in Pajon cages (50 x 57 x 75 cm)
- Diet: ad libitum 110C pelleted diet (SAFE, Augy, France).
- Water: ad libitum filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days


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


IN-LIFE DATES: From: 08 April 2008 To: 04 May 2008

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg of the test item in its original form

Duration of treatment / exposure:

One application to one eye and there was no rinsing after administration. The other eye acted as control.

Observation period (in vivo):

up to 12 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
The test material was not removed after exposure


SCORING SYSTEM:

Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
. no swelling ...............................................................................................................................0
. any swelling above normal (includes nictitating membranes) ...................................... ..1
. obvious swelling with partial eversion of lids......................................................................2
. swelling with lids about half-closed......................................................................................3
. swelling with lids more than half-closed .............................................................................4


Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal ...............................................................................................................0
. a number of blood vessels definitely hyperemic (injected).................................................1
. diffuse, crimson colour, individual vessels not easily discernible ....................................2
. diffuse, beefy red........................................................................................................................3

Discharge
. absence of discharge .............................................................................................................. .0
. slight discharge (does not include small amounts normally found in
inner canthus) ..............................................................................................................................1
. discharge with moistening of lids and hairs adjacent to lids...............................................2
. discharge with moistening of lids and hairs on wide area around the eye........................3

Iris lesions
. normal ..........................................................................................................................................0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal
hyperemia, or injection, any of these or combination of any thereof, iris still
reacting to light (sluggish reaction is positive) .......................................................................1
. no reaction to light, haemorrhage, gross destruction (any or all of these) ......................2

Corneal lesions
Degree of opacity (area most dense taken for reading)
. no ulceration or opacity..............................................................................................................0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre),
details of iris clearly visible ..........................................................................................................1
. easily discernible translucent area, details of iris slightly obscured ...................................2
. nacreous areas, no details of iris visible, size of pupil barely discernible ..........................3
. opaque cornea, iris not discernible through the opacity.......................................................4

Area of opacity
. one quarter (or less) but not zero..............................................................................................1
. greater than one quarter but less than a half...........................................................................2
. greater than one half but less than three quarters..................................................................3
. greater than three quarters up to whole area. .........................................................................4

Any other lesions observed were noted.

TOOL USED TO ASSESS SCORE: UV lamp/ 0.5% sodium fluorescein

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

2.4

Max. score:

4

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Remarks:

2 rabbits

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7-12 days

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity intensity

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

animal #1

Remarks:

No. 62

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

animal #2

Remarks:

No. 73

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 3-6 days

Irritation parameter:

cornea opacity score

Remarks:

Opacity area

Basis:

animal #3

Remarks:

No. 816

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 3-6 days

Irritant / corrosive response data:

Slight to marked chemosis was observed in all animals from day 1 until day 6, 9 or 11.
Slight to severe redness of the conjunctiva was noted in all animals from day 1 until day 6 (one animal) or 11 (two animals).
A clear to whitish purulent discharge was noted in all animals from day 1 until day 3 (two animals) or 4 (one animal).
An iritis was noted in 2/3 animals from day 1 until day 3 or 5 and on day 2 in 1/3 animals.
A slight or moderate corneal opacity was recorded in 2/3 animals on days 2 and 3. In the third animal, a slight to severe corneal opacity, which covered sometimes the whole area of the cornea, was noted from day 1 until day 5.
Brownish area on the third eyelid was observed in 1/3 animals from day 7 until day 11.
Mean scores calculated for each animal over 24, 48 and 72 hours were 2.0, 2.3 and 3.0 for chemosis, 2.3, 2.0 and 2.7 for redness of the conjunctiva, 0.7, 0.3 and 1.0 for iris lesions and 1.0, 1.0 and 2.3 for corneal opacity.

Table 1a: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)

Rabbit Number	Region of Eye	Description of ocular reactions	Scores				Mean irritation score (1)	Interpretation (+) (-)
			1 hour Day 1	24 hours Day 2	48 hours Day 3	72 hours Day 4
62	Conjunctivae	Chemosis	2	2	2	2	2.0	(+)
		Redness	3	3	2	2	2.3	(-)
		Discharge	1	2	1	0	1.0
	Iris		1	1	1	0	0.7	(-)
	Corneal opacity	Intensity	0	2	1	0	1.0	(-)
		Area	0	1	1	0	0.7
	Other		*	*	*	*
	Fluorescein		/	U	U	U
73	Conjunctivae	Chemosis	2	3	2	2	2.3	(+)
		Redness	2	2	2	2	2.0	(-)
		Discharge	2	2	1	0	1.0
	Iris		0	1	0	0	0.3	(-)
	Corneal opacity	Intensity	0	2	1	0	1.0	(-)
		Area	0	1	1	0	0.7
	Other		*	*	*	*
	Fluorescein		/	U	U	U
816	Conjunctivae	Chemosis	2	3	3	3	3.0	(+)
		Redness	2	2	3	3	2.7	(+)
		Discharge	2	S	S	S	(2)
	Iris		1	1	1	1	1.0	(+)
	Corneal opacity	Intensity	2	2	3	2	2.3	(+)
		Area	2	4	4	2	3.3
	Other		Su	*	*	*
	Fluorescein		/	U	U	U

 

(1): mean of scores on days 2, 3 and 4       (2): not calculable

(+): irritant according to EEC criteria           U: fluorescein (batch No. L653 & P756)

(-): non-irritant according to EEC criteria     /: fluorescein not used

S: whitish purulent discharge Su: residual test item

*: none

Table 1b: Individual ocular examinations of the scores recorded for each animal (from Day 5 to Day 12)

Rabbit Number	Region of Eye	Description of ocular reactions	Scores
			Day 5	Day 6	Day7	Day 8	Day 9	Day 10	Day 11	Day 12
62	Conjunctivae	Chemosis	1	1	0	-	-	-	-	-
		Redness	1	1	0	-	-	-	-	-
		Discharge	0	0	0	-	-	-	-	-
	Iris		0	0	0	-	-	-	-	-
	Corneal opacity	Intensity	0	0	0	-	-	-	-	-
		Area	0	0	0	-	-	-	-	-
	Other		*	*	*	-	-	-	-	-
	Fluorescein		/	/	/	-	-	-	-	-
73	Conjunctivae	Chemosis	1	1	1	1	1	1	1	0
		Redness	2	2	2	2	1	1	1	0
		Discharge	0	0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0	0
	Corneal opacity	Intensity	0	0	0	0	0	0	0	0
		Area	0	0	0	0	0	0	0	0
	Other		*	*	*	*	*	*	*	*
	Fluorescein		/	/	/	/	/	/	/	/
816	Conjunctivae	Chemosis	2	1	1	1	1	0	0	0
		Redness	2	2	1	1	1	1	1	0
		Discharge	0	0	0	0	S	S	0	0
	Iris		1	0	0	0	0	0	0	0
	Corneal opacity	Intensity	1	0	0	0	0	0	0	0
		Area	1	0	0	0	0	0	0	0
	Other		*	*	ZB	ZB	ZB	ZB	ZB	*
	Fluorescein		U	U	/	/	/	/	/	/

 *: none                                                                       ZB: brownish area on the third eyelid

U: fluorescein (batch No. P756)                                  -:  ocular examination not performed

/: fluorescein not used

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the experimental conditions of the study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was irritant when administered by the ocular route to rabbits.
Based on the read-across justification potassium perchlorate can be considered as eye irritating.

Executive summary:

The potential of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th April 2002) and EC (2004/73/EC, B.5, 29th April 2004) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Under the experimental conditions of the study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was irritant when administered by ocular route to rabbits and should be classified as Irritant, Category 2 under CLP (GHS).

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available