Ammonium perchlorate

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Anhydrous Sodium Perchlorate

IUPAC Name:

Anhydrous 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 (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 or test system 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:

other: 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)

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.