Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
10 - 24 April 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 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Anhydrous Sodium Perchlorate
- Physical state: white powder
- Analytical purity: 98.21%
- Purity test date: 10/01/08
- Lot/batch No.: GRL 0005/08
- Expiration date of the lot/batch: February 2010
- Storage condition of test material: Room Temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: Males 367 ± 12g; Females 237 ± 7g
- Housing:
Acclimation period: 1 - 7 of same sex in polycarbonate cages with stainless steel lid (48x27x20cm).
Treatment period: individually housed in polycarbonate cages with stainless steel lid (35.5x23.5x19.3cm). Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet: SSNIFF R/M-H pelleted maintenance diet (ad libitum); SSNIFF Spezialdiaten GmbH, Soest, Germany).
- Water: drinking water filtered by a FG Millipore memmbrane (0.22µm) ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30-70%
- Air changes (per hr): 12 cycles/hr of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12/h (7:00-19:00)


IN-LIFE DATES: From: 10 April 2008 To: 24 April 2008

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Males approx. 5x7cm; Females approx. 5x6cm
- % coverage: approx. 10%
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.


REMOVAL OF TEST SUBSTANCE
- Removed using a dry cotton pad
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): as a single dose at 2000mg/kg adjusted according to the bodyweight determined on the day of
treatment
- Concentration (if solution): Applied as its original formbut purified water was used in order to moisten the test item and ensure a good contact with the skin
- Constant volume or concentration used: yes
- For solids, paste formed: no


VEHICLE
Not applicable
Duration of exposure:
24 hours
Doses:
A single dose
No. of animals per sex per dose:
5 animals/sexe/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observed for clinical signs frequently soon after dosing and at least once per day thereafter up until day 15.
Bodyweights recorded just before dose administration on day 1 and then on days 8 and 15
- Necropsy of survivors performed: yes
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths during the study
Clinical signs:
No systemic clinical signs were observed during the study. Crusts were noted in 1/5 males (No. 5) from day 10 until day day 15 (end of the
observation period)
Body weight:
When compared to CIT historical control animals, a slightly lower bodyweight gain was noted in 1/5 females (No. 7) between day 1 and day 8;
it returned to normal thereafter
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities
Other findings:
None

Any other information on results incl. tables

No deaths and no systemic clinical signs were observed during the study (Table 1). Crusts were noted in 1/5 males from day 10 until day 15, (Table 2). When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/5 females between day 1 and day 8; it returned to normal thereafter. The body weight gain of the other animals was not affected by treatment with the test item (Tables 3 & 4). No apparent abnormalities were observed at necropsy in any animal.

Table 1: Individual clinical signs and mortality

Dose-level (mg/kg)

Time

Animals

Mortality

Clinical signs

2000

Males

Females

30 mins

01-02-03-04-05

06-07-08-09-10

No

None

2 hours

Day 2 – Day 15

 

Table 2: Cutaneous reactions

Dose-level (mg/kg)

Time

Animals

Cutaneous reactions

2000

Males

Females

Day 2 to Day 9

01-02-03-04-05

06-07-08-09-10

None

 

Day 2 – Day 15

05

-

Crusts

01-02-03-04

06-07-08-09-10

None

  

 Table 3: Individual and mean body weight and weekly body weight change (g)

Dose level

(mg/kg)

Sex

Animals

Days

1

(1)

8

(1)

15

2000

Male

01

371

37

408

55

463

02

380

43

423

49

472

03

373

45

418

51

469

04

353

36

389

49

438

05

356

37

393

50

443

 

Mean

367

40

406

51

457

SD

12

4

15

2

16

 

2000

Female

06

240

35

275

15

290

07

233

12

245

26

271

08

235

36

271

22

293

09

247

16

263

15

278

10

229

38

267

32

299

 

 

 

 

 

 

Mean

237

27

264

22

286

SD

7

12

12

7

11

(1): bodyweight gain 

SD: standard deviation

Table 4: Body weight - CIT historical data of control animals dosed (purified water) by dermal route

Volume

(mL/kg)

Sex

 

Days

1

(1)

8

(1)

15

5

Male

Mean

328

44

372

46

419

SD

39

13

35

8

37

n

29

29

29

29

29

 

5

Female

Mean

214

25

239

18

257

SD

11

11

16

9

20

n

30

30

30

30

30

(1): bodyweight gain

SD: standard deviation

n: number of animals

Applicant's summary and conclusion

Interpretation of results:
not classified
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 dermal LD50 of the test item was higher than 2000mg/kg in rats
Executive summary:

The acute dermal toxicity of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was evaluated in rats according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B.3, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Under the experimental conditions of this study, the dermal LD0 of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was higher than 2000 mg/kg in rats.