Ashes (residues), cenospheres

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

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

Adequacy of study:

supporting study

Study period:

10 Dec 1950 - 14 Apr 1954

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1955

Materials and methods

Objective of study:

absorption

distribution

excretion

Principles of method if other than guideline:

Fly ash derived from coal combustion was fed at 0, 300 and 1500 g / animal / day to cows over a period of 2 years.
After two years, the chemical composition of milk, blood, urine and faeces samples were analysed.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ashes (residues), coal

EC Number:

931-322-8

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Ashes (residues), coal

Details on test material:

- Name of test material (as cited in study report): Fly ash from (black) coal combustion, Scholven, Germany
- Other: Further details are given in the tables below

Radiolabelling:

no

Test animals

Species:

cattle

Strain:

other: Schwarzbunte Niederungsrasse

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Oldenburg, Germany (a geographical region which was assumed to be free of fly ash from coal combustion)
- Age at study initiation: 2.75 - 6.75 years
- Weight at study initiation: 535 - 710 kg
- Housing: Cattle pen; the animals were allowed to graze.
- Diet (e.g. ad libitum): fodder beed, hay and straw (ad libitum) supplemented with mash.
At their arrival the animals were carefully clinically examined. All animals were in good nutritional state and showed no symptoms of illness.
Some animals were seropositive for tuberculosis.

ENVIRONMENTAL CONDITIONS
All animals were kept on farm without contact to other cattle.
The cattle pen was always kept clean, dry and ventilated with fresh air.

IN-LIFE DATES:
Exposure period: From: December 10th, 1950 To: December 15th, 1953
Post exposure observation period: From: December 16th, 1953 To: April 14th, 1954

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:
The test substance was mixed with the daily food.
Animals were fed twice a day in individual boxes to assure the intake of the individual portions.

DIET PREPARATION
In the high dose group, the fly ash was mixed with soaked fodder beed and mash, to improve the taste and to ascertain the daily intake of the high amounts of fly ash.

Duration and frequency of treatment / exposure:

2 years, twice daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

300 other: g/animal/day

Doses / concentrations 2

Dose / conc.:

1 500 other: g/animal/day

Remarks:

2 high-dose animals received temporarily up to 1800 g/animal/day

No. of animals per sex per dose / concentration:

3

Control animals:

yes, concurrent no treatment

Positive control reference chemical:

not applicable

Details on dosing and sampling:

PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Body fluids sampled: urine, faeces, blood, milk
- Time and frequency of sampling: once on December 10, 1952

Statistics:

not applicable

Results and discussion

Any other information on results incl. tables

Analysis of milk samples collected on December 10^th, 1952:

(Average values in % determined from two different laboratories in parallel)

Animal	Treatment up to the sampling date	Dry residue	Ash	CaO	MgO	P2O5
1	concurrent no treatment	12.9	0.74	0.172	0.0144	0.212
2	concurrent no treatment	15.8	0.89	0.267	0.0222	0.276
3	concurrent no treatment	10.3	0.71	0.136	0.0155	0.185
4	300 g fly ash per day	11.2	0.78	0.173	0.0170	0.235
5	300 g fly ash per day	14.7	0.82	0.197	0.0194	0.299
6	300 g fly ash per day	14.1	0.71	0.152	0.0204	0.159
7	1500 - 1800 g fly ash per day	15.3	0.69	0.161	0.0161	0.220
8	1500 - 1800 g fly ash per day	14.1	0.73	0.155	0.0144	0.213
9	1500 - 1800 g fly ash per day	10.3	0.73	0.151	0.0153	0.224

Applicant's conclusion:

Two years of oral administration of two different doses of fly ash did not influence the composition of the milk regarding the analysed parameters.

 

Analysis of blood samples collected on December 10^th, 1952:

(Average values in % determined from two different laboratories in parallel)

Animal	Treatment up to the sampling date	Dry residue	Ash	CaO	MgO	P2O5	Fe2O3
1	concurrent no treatment	19.2	1.37	0.0127	0.0058	0.0374	0.0534
2	concurrent no treatment	19.9	1.03	0.0110	0.0060	0.0380	0.0544
3	concurrent no treatment	18.7	1.15	0.0116	0.0061	0.0371	0.0435
4	300 g fly ash per day	19.5	1.22	0.0133	0.0062	0.0396	0.0502
5	300 g fly ash per day	19.2	1.36	0.0094	0.0077	0.0333	0.0572
6	300 g fly ash per day	19.6	1.13	0.0101	0.0068	0.0350	0.0430
7	1500 - 1800 g fly ash per day	20.3	1.16	0.0105	0.0071	0.0359	0.0480
8	1500 - 1800 g fly ash per day	18.3	0.98	0.0112	0.0062	0.0362	0.0489
9	1500 - 1800 g fly ash per day	19.3	1.12	0.0116	0.0077	0.0345	0.0547

Applicant's conclusion:

Two years of oral administration of two different doses of fly ash did not influence the composition of the blood regarding the analysed parameters.

 

Analysis of urine samples collected on December 10^th, 1952

(Average values in % determined from two different laboratories in parallel)

Animal	Treatment up to the sampling date	pH	Glucose	Protein	Dry residue	CaO	MgO^a	P2O5
1	concurrent no treatment	8.14	neg.	neg.	6.84	0.0055	0.0170	0.0027
2	concurrent no treatment	8.20	neg.	neg.	5.18	0.0018	0.0221	0.0024
3	concurrent no treatment	8.18	neg.	neg.	5.41	0.0011	0.0261	0.0016
4	300 g fly ash per day	8.36	neg.	neg.	5.33	0.0066	0.0090	0.0013
5	300 g fly ash per day	8.26	neg.	neg.	4.53	0.00097	0.0080	0.0014
6	300 g fly ash per day	8.34	neg.	neg.	5.11	0.0043	0.0302	0.0031
7	1500 - 1800 g fly ash per day	8.08	neg.	neg.	3.85	0.0084	0.0100	0.0013
8	1500 - 1800 g fly ash per day	8.40	neg.	neg.	6.33	0.0041	0.0357	0.0022
9	1500 - 1800 g fly ash per day	8.38	neg.	neg.	5.80	0.0233	0.0411	0.0025

^aMgO was only analysed from one laboratorium

Applicant's conclusion:

Two years of oral administration of two different doses of fly ash did not influence the composition of the urine regarding the analysed parameters.

 

Analysis of faeces sampled on December 10^th, 1952

(Values in % of fresh faeces)

Animal	Treatment up to the sampling date	Ash	SiO2	Al2O3	Fe2O3	MgO	CaO	SO3	P2O5
1	concurrent no treatment	2.77	1.51	0.119	0.066	0.118	0.270	0.057	0.183
2	concurrent notreatment	2.23	1.11	0.086	0.054	0.150	0.250	0.044	0.164
3	concurrent no treatment	2.28	1.13	0.091	0.062	0.111	0.259	0.052	0.167
4	300 g fly ash per day	2.68	1.32	0.296	0.142	0.131	0.255	0.054	0.190
5	300 g fly ash per day	2.36	1.17	0.240	0.148	0.111	0.240	0.054	0.170
6	300 g fly ash per day	2.98	1.55	0.431	0.201	0.131	0.350	0.077	0.270
7	1500 - 1800 g fly ash per day	4.81	2.49	0.716	0.615	0.286	0.372	0.107	0.182
8	1500 - 1800 g fly ash per day	6.21	2.84	0.827	0.643	0.352	0.477	0.135	0.246
9	1500 - 1800 g fly ash per day	4.76	2.31	0.644	0.506	0.288	0.492	0.105	0.208

^aMgO was only analysed from one laboratorium

Applicant's conclusion:

Two years of oral administration of two different doses of fly ash influenced the ash and mineral contents of the faeces in a dose-dependent manner.

Analysis of trace elements in liver and bone samples:

At the end of the 3-year experiment duration, liver and bone samples of all animals were analysed for their contents of Arsenic, Manganese, Lead, Iron, Copper, Zinc and Cobalt. Bones were additionally analysed for their CaO and P₂O₅content.

In summary, there was no significant influence of the fly ash administration on the trace element contents in liver and bone samples.

Applicant's summary and conclusion

Conclusions:

No bioaccumulation potential based on study results
The chemical analyses of milk, blood, urine and faeces indicate, that no systemic absorption after oral administration of 1850 mg/kg/day of the test substance occured.

Executive summary:

Fly ash derived from coal combustion in Scholven, Germany was fed at 0, 300 and 1500 g/animal/day to cows over a period of 3 years. After two years the control and intermediate dose groups were exchanged and therefore as far as possible only the results from this time point were taken into the present considerations.

Body weight development in cows were not disturbed by the oral administration of fly ash. Because treated animals showed a slightly higher milk production rate than control animals, the general condition of treated animals was considered to be better. Chemical analyses of milk, blood, urine and faeces samples after two years indicate that the test substance was practically not bioavailable for resorption.