Synthetic wollastonite

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 11 May 2010 and 15 June 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Kieselguhr, soda ash flux-calcined

EC Number:

272-489-0

EC Name:

Kieselguhr, soda ash flux-calcined

Cas Number:

68855-54-9

Molecular formula:

SiO2

IUPAC Name:

Dioxosilane (Kieselguhr, soda ash flux-calcined)

Details on test material:

Sponsor's identification: soda-ash flux calcined kieselguhr
Description : white powder
Lot number : 211184
Date received : 10 February 2010
Expiry date : 31 December 2013
Storage conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Oxon, UK
- Age at study initiation: Eight to twelve weeks of age
- Weight at study initiation:
- Fasting period before study: Overnight fast immediately before dosing
- Housing: Housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: 2014 Teklad Global Rodent diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 to 70%
- Air changes: At least fifteen changes per hour
- Photoperiod: Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential

Doses:

300 mg/kg (preliminary study)
2000 mg/kg (main study)

No. of animals per sex per dose:

One animal treated at a dose level of 300 mg/kg and a total of five animals were treated at a dose level of 2000 mg/kg in the study

Details on study design:

Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on day 0 (the day of dosing) and on days 7 and 14.

Results and discussion

Preliminary study:

Individual clinical observations and mortality data are given in Table 1. There was no mortality. No signs of systemic toxicity were noted during the observation period. Individual bodyweights and bodyweight changes are given in Table 2. The animal showed expected gains in bodyweight over the observation period. Necropsy findings are given in Table 3. No abnormalities were noted at necropsy. Based on the results at a dose level of 300 mg/kg, a dose level of 2000 mg/kg bodyweight was investigated.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: Hunched posture was noted in all animals. Ataxia was also noted in one animal. All animals appeared normal three days after dosing. Individual clinical observations and mortality data are given in Table 4

Gross pathology:

No abnormalities were noted at necropsy. Individual necropsy findings are given in Table 6

Any other information on results incl. tables

Table 1: Individual Clinical Observations and Mortality Data -300mg/kg

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
300	1-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0=     No signs of systemic toxicity

Table 2: Individual Bodyweights and Bodyweight Changes -300mg/kg

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
300	1-0 Female	166	186	198	20	12

Table 3: Necropsy Findings -300 mg/kg

Dose Level mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
300	1-0 Female	Killed Day 14	No abnormalities detected

Table 4: Individual Clinical Observations and Mortality Data -2000mg/kg

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	2-0 Female	0	HA	H	H	H	H	0	0	0	0	0	0	0	0	0	0	0	0
	3-0 Female	0	H	H	H	H	H	0	0	0	0	0	0	0	0	0	0	0	0
	3-1 Female	0	H	H	H	H	H	0	0	0	0	0	0	0	0	0	0	0	0
	3-2 Female	0	H	H	H	H	H	0	0	0	0	0	0	0	0	0	0	0	0
	3-3 Female	0	H	H	H	H	H	0	0	0	0	0	0	0	0	0	0	0	0

0=      No signs of systemic toxicity

A =      Ataxia

H =      Hunched posture

Table 5: Individual Bodyweights and Bodyweight Changes -2000mg/kg

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
2000	2-0 Female	178	199	204	21	5
	3-0 Female	187	192	212	5	20
	3-1 Female	196	203	216	7	13
	3-2 Female	186	195	213	9	18
	3-3 Female	189	195	203	6	8

Table 6: Individual Necropsy Findings -2000mg/kg

Dose Level mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
2000	2-0 Female	Killed Day 14	No abnormalities detected
	3-0 Female	Killed Day 14	No abnormalities detected
	3-1 Female	Killed Day 14	No abnormalities detected
	3-2 Female	Killed Day 14	No abnormalities detected
	3-3 Female	Killed Day 14	No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The acute oral median lethal dose (LD50) of kieselguhr soda ash flux calcined was >2000mg/kg and is therefore not classified in accordance with CLP Regulation (EC) no. 1272/2008