Slimes and Sludges, blast furnace and steelmaking

Endpoint summary

Description of key information

The testing of acute oral toxicity was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. The test substance wasadministered in a single dose as suspension in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats. 
A study was performed in accordance with the OECD Guidelines for Testing of Chemicals (2009) No. 403 “Acute Inhalation Toxicity” and was designed to comply with Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008, with the exception that only six animals (three males and three females) were utilized during the “limit test”.
According to column 2 of REACH Annex VIII, section 8.5 (Acute toxicity) was not carried out the test of acute dermal toxicity (8.5.3) by reason that inhalation exposure by dust of the test material was more probable than exposure by dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23.11.2009 - 8.12.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Age at study initiation: 8-10 weeks
- Weight at study initiation: see Table No. 1
- Fasting period before study: 20 hours
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): ST 1 BERGMAN – standard pelleted diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C, permanently monitored
- Humidity (%): 30-70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 1 ml/100 g bw
- Lot/batch no. (if required): 4683401

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 rats (F) per dose 2000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the first day twice (30 minuts and 3 hours after application), 2nd-14th day twice (morning and afternoon)
- Necropsy of survivors performed: yes
- Other examinations performed: changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0 dead animals

Clinical signs:

other: 30 minuts: gibbous posture 3 hours: gibbous posture, piloerection, in some cases increased response to stimuli 2nd-14th day: no clinical signs of intoxication

Gross pathology:

Any tested animals had no pathologic changes.

Table No. 1: Individual body weight - 2000 mg/kg (steps No. 1 and No. 2)

dose (mg/kg) (step No.)	animal No.	body weight (g)			body weight gain (g)
		before application	8 days post application	15 days post application	0-8 days post application	8-15 days post application
2000(1)	1	170.31	203.04	222.17	32.73	19.13
	2	154.85	184.37	200.53	29.52	16.16
	3	153.79	189.69	207.48	35.90	17.79
	mean	159.65	192.37	210.06	32.72	17.69
	SD	9.25	9.62	11.05	2.60	1.21
2000(2)	4	157.19	185.52	196.43	28.33	10.91
	5	154.83	181.79	203.33	26.96	21.54
	6	166.43	203.67	212.18	37.24	8.51
	mean	159.48	190.33	203.98	30.84	13.65
	SD	6.13	11.71	7.86	4.56	5.66

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the study results the value of LD50 of the test substance, Slimes and Sludges, blast furnace and steelmaking, (in female rats) is higher than 2000 mg/kg of body weight.

Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance,Slimes and Sludges, blast furnace and steelmaking,after a single oral administration to Wistar rats.

The testing was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test substance wasadministered in a single dose as suspension in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats.

The dosing was performed sequentially in two groups of three females: group No. 1 - first step using the startingdose of 2000 mg/kgofbody weight and group No.2 - second step using the same dose.

The test substance administered at thedose of 2000 mg/kgcaused no death of animals.  

Clinical signs of intoxication (gibbous posture) were observed 30 minutes after application and 3 hours after application clinical signs of intoxication (gibbous posture, piloerection, increased response to stimuli) were observed in all six animals. 24 hours after application all animals were without clinical symptoms.

No pathologic macroscopic changes were diagnosed during pathological examination.

According to the study results the value ofLD₅₀of the test substance for female rats is higher than 2000 mg/kg of body weight.

The classification of the test substance toxicity was performed according to the Directive 67/548/EEC, Annex VI. part 3.1.5. and 3.2.

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test substanceSlimes and Sludges, blast furnace and steelmaking did not fallinto any of quoted categories of toxicityandhasno obligatory labelling requirementin this respect.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2.7.2010-4.8.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation:200-350 g
- Housing: solid floor polypropylene cages with stainless steel lids
- Diet (e.g. ad libitum): Harlan 2014 Rodent Diet ad libitum with the exception of the exposure period (Harlan Laboratories UK Ltd., Oxon, UK)
- Water (e.g. ad libitum): drinking water ad libitum with the exception of the exposure period
- Acclimation period: min 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70 %
- Air changes (per hr): 15× pre hour
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Solid Aerosol Generator SAG 410 (TOPAS GmbH, Dresden, Germany)
- Exposure chamber volume: cca 30 l
- Source and rate of air: compressed air was passed through a water trap and respiratory quality filters before it was introduced into the SAG 410
- System of generating particulates/aerosols: SAG 410
- Method of particle size determination: Marple Personal Cascade Impactor (westech IS Ltd., Beds., UK) with 9.8, 6.0, 3.5, 1.6, 0.93 and 0.52 µm cut points
- Treatment of exhaust air: exhaust air was conducted through scrubber and high efficiency filter
- Temperature, humidity, pressure in air chamber: temperature 21°C, humidity 53-62 %

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric method (increase of weight of the glass filter per defined time)
- Samples taken from breathing zone: no

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
cut point (µm) / mean weight (mg)
9.8 / 0.29
6.0 / 0.27
3.5 / 0.39
1.6 / 0.42
0.93 / 0.60
0.52 / 0.27
<0.52 / 0.05
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.86 µm / 2.60

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

mean concentration 5.12 mg/l

No. of animals per sex per dose:

3 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
+ Clinical signs: hourly during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days
+ Body weight: prior to treatment and on days 1, 3, 7 and 14
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.12 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No dead animals.

Clinical signs:

other: Any evidence of overt toxicity were recorded at each observation.

Body weight:

Variations in bodyweight gain are frequently seen for female animals of this strain and age during this type of study and, in isolation, are considered not to be significant.

Gross pathology:

With the exception of one male and one female animal, all animals exhibited dark patches on the lungs at necropsy.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No deaths occurred in a group of six rats exposed to a mean achieved atmosphere concentration of 5.12 mg/l for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of Slimes and Sludges, blast furnace and steelmaking, in the Wistar strain rat, was greater than 5.12 mg/l.

Executive summary:

Introduction

A study was performed to assess the acute inhalation toxicity of the test item. The method used followed that described in the OECD Guidelines for Testing of Chemicals (2009) No. 403 “Acute Inhalation Toxicity” and was designed to comply with Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008, with the exception that only six animals (three males and three females) were utilized during the “limit test”.

Methods

A group of six Wistar strain rats (three males and three females) was exposed to a dust atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period.

Results

The mean achieved atmosphere concentration was as follows:

Atmosphere Concentration Mean Achieved: 5.12 mg/l

The characteristics of the achieved atmosphere were as follows:

Mean Mass Median Aerodynamic Diameter: 2.86 µm

Inhalable Fraction (<4 µm): 63.9 %

Geometric Standard Deviation: 2.60

The mortality data were summarised as follows:

Male: 0/3

Female: 0/3

Total: 0/6

Clinical Observations: Common abnormalities noted during the study included increased respiratory rate, generalised black fur staining by the test item, hunched posture, piloerection and wet fur. Animals recovered to appear normal on Day 4 post exposure.

Bodyweight: All animals exhibited a slight bodyweight loss on the first day post exposure. Normal bodyweight development was noted for all animals during the remainder of the recovery period.

Necropsy: With the exception of one male and one female animal, all animals exhibited dark patches on the lungs at necropsy.

Conclusion

No deaths occurred in a group of six rats exposed to a mean achieved atmosphere concentration of 5.12 mg/l for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of Slimes and Sludges, blast furnace and steelmaking, in the Wistar strain rat, was greater than 5.12 mg/l.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5.12 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Both of the tests signalise low acute toxicity the test item:

LD50 > 2000 mg/kg bw (rat oral)

LC50 > 5.12 mg/l (rat, inhalation, 4 h)

Justification for classification or non-classification

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test substance Slimes and Sludges, blast furnace and steelmaking did not fall into any of quoted categories of toxicity both oral and inhalation, and has no obligatory labelling requirement in this respect.