Cobalt zinc silicate blue phenacite

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 401; GLP compliant)

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:

1999-12-22 to 2000-01-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 1997-01-08

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: males: 36 days; females: 45 days
- Weight at study initiation: males: 185 - 197 g; females: 170 - 179 g
- Fasting period before study: feeding was discontinued approximately 16 hours before administration
- Housing: kept in groups of 2 or 3 animals in MAKROLON cages (type III); bedding material: granulated textured wood (Granulate A2, J. Brandenburg, D-49424 Goldenstedt)
- Diet: Altromin 1324 (ALTROMIN GmbH, D-32791 Lage/Lippe)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity: 60% ± 20% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose gel

Details on oral exposure:

VEHICLE
- Batch no.: 96100910
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration. During the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, automatic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study, and at death. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes, at the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded.

Statistics:

The LD50 could not be calculated because no lethality occurred.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

There were no substance-related findings.

Body weight:

Body weight gain occurred. There was no inhibition of body weight gain.

Gross pathology:

No autopsy findings were made.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (male and female rats) > 2000 mg/kg bw
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

One study (Leuschner, 2000), OECD Guideline 401 rated as key study (Klimisch 1), is available and which is used for (non) classification. The determined LD50 value is >2000 mg/kg bw.

Justification for classification or non-classification

Acute oral toxicity

The substance is not acutely toxic via the oral route based on an acute oral toxicity test (OECD 401) and does not require classification according to Regulation (EC) No 1272/2008 and subsequent adaptations.