Slags, silicomanganese-manufg.

Endpoint summary

Description of key information

ORAL
LD50 > 2000 mg/kg bw, rat (male/female), EU Method B.1, Ferroatlantica (2003)
DERMAL
LD50 > 2000 mg/kg bw, rat (male/female), EU Method B.3, Ferroatlantica (2003)

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:

2003-1-24 to 2003-2-7

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

yes

Remarks:

no raw data

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 91.8 - 98.3 g (males); 92.5-97.7 g (females)
- Fasting period before study: yes (length not stated)
- Housing: polypropylene, with vents on top, with dimensions 445(w) x 695 (l) x 290 (h), allowing 10 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2mL

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, organ weights, general state of animal, observable external alterations

Statistics:

not reported

Preliminary study:

A study had been performed several years earlier that indicated 5000 mg/kg caused no mortalities. This was justification for starting at 2000 mg/kg in this study.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no mortalities

Clinical signs:

other: not reported

Gross pathology:

No apparent macroscopic injuries in any of the observed organs; colour and consistency were normal.

Other findings:

- Other observations: After administration of the substance there was slight hair erection, which disappeared in 1-2 hours.

The activity and behaviour were not affected, and at the end of the 14 days they were apparently normal. No changes were detected in the health status of the conjunctiva and mucous membranes. The appearance and colour of skin and hair was normal.

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study the acute oral LD50 of the test substance was determined to be in excess of 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.1.

 During the study 5 male and 5 female rats received 2000 mg/kg bw test substance, at a dose volume of 2 mL, via gavage. Following dosing, the animals were observed for 14 days. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.

Therefore, under the conditions of the study the acute oral LD50 of the substance was determined to be in excess of 2000 mg/kg bw.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study was conducted to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results. The study was therefore assigned a reliability score of 2 in line with the criteria of Klimisch (1997).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-1-24 to 2003-2-7

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

no raw data for each animal

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 91.3 -99.7 g (males); 94.0 - 101.8 g (females)
- Housing: polypropylene cages with vents on top, with dimensions 445(w) x 695 (l) x 290(h) allowing 10 animals per cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal region
- % coverage: >10%
- Type of wrap if used: gauze pad and hypoallergenic medical tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hr


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2mL of substance aqueous suspension
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: performed but no details
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, organ weights, histopathology, general condition, external alterations

Statistics:

Not reported

Preliminary study:

A previous study conducted several years earlier gave no mortality at 400 mg/kg and thus the use of 2000 mg/kg for this study.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: Not reported

Gross pathology:

No apparent macroscopic injuries in any of the observed organs; colour and consistency were normal.

Other findings:

- Other observations:
General condition: After the administration of the substance there was slight hair erection, which disappeared in 1-2 hrs. The activity and behaviour were not affected, and at the end of the 14 days they were normal.

External alterations: No changes were detected in the health status of the conjunctiva and mucous membranes. Initially superficial injuries were observed in the dorsal area that was in contact with the test substance but these healed by themselves during the first week.

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study the acute dermal LD50 of the test substance was determined to be in excess of 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.3.

During the study 5 male and 5 female rats received a dermal application of 2000 mg/kg bw test substance. Twenty four hours after application the test site was washed to remove the test substance. The animals were observed for a further 13 days. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.

Therefore, under the conditions of the study the acute dermal LD50 of the substance was determined to be in excess of 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study was conducted to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results. The study was therefore assigned a reliability score of 2 in line with the criteria of Klimisch (1997).

Additional information

Oral

The acute oral toxicity of the substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.1.

 During the study 5 male and 5 female rats received 2000 mg/kg bw test substance, at a dose volume of 2 mL, via gavage. Following dosing, the animals were observed for 14 days. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.

Therefore, under the conditions of the study the acute oral LD50 of the substance was determined to be in excess of 2000 mg/kg bw.

Inhalation

In accordance with column 2 of REACH Annex VIII, testing by the inhalation route is not appropriate, taking into account the very low level of particles of an inhalable size, based on results of particle size distribution study which indicated < 3.5 % w/w of particles are less than 100 microns diameter.

Dermal

The acute dermal toxicity of the test substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.3.

During the study 5 male and 5 female rats received a dermal application of 2000 mg/kg bw test substance. Twenty four hours after application the test site was washed to remove the test substance. The animals were observed for a total of 1 days following exposure. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.

Therefore, under the conditions of the study the acute dermal LD50 of the substance was determined to be in excess of 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Only one study is available.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, testing by the inhalation route is not appropriate, taking into account the very low level of particles of an inhalable size, based on results of particle size distribution study which indicated < 3.5 % w/w of particles are less than 100 microns diameter.

Justification for selection of acute toxicity – dermal endpoint
Only one study is available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to acute toxicity.