Frits, chemicals

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

12th June - 19th June 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, guideline study, available as an unpublished report with minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EN ISO 10993-11 tests for systemic toxicity

Deviations:

no

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

dust containing nickel- FC911

Test animals

Species:

mouse

Strain:

Swiss

Sex:

not specified

Details on test animals or test system and environmental conditions:

Test animals were 5 healthy Swiss mice weighing between 30-38g.

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

unchanged (no vehicle)

Details on exposure:

Five mice received an intraperitonel dose (1 ml/20g) of sample (0.2 g/ml). Another 5 mice received an intraperitoneal injection of the negative control solution (physiological saline). The mice were observed for 72 h for induced reactions and survival.

Doses:

intraperitonel dose (1 ml/20g) of sample (0.2 g/ml)

No. of animals per sex per dose:

% animals per dose, sex not reported

Control animals:

yes

Details on study design:

Not applicable

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

other: clinical observation

Effect level:

> 0.2 other: g/ml/20g bw

Based on:

test mat.

Remarks on result:

other: no effect

Mortality:

No mortality was observed.

Clinical signs:

No clinical signs were observed. Observations were made for hypokinesia, dyspnea, abdominal irritation, ptosis, dihorroea, prostration, cyanosis, tremors and death.

Body weight:

Not studied.

Gross pathology:

No gross pathology reported.

Other findings:

Not applicable

Applicant's summary and conclusion

Conclusions:

A 0.2 g/ml solution of test material FC911 was injected into 5 mice via the intraperitoneal route at a dose of 1 ml/20g body weight. This concentration had no effect on the animals when compared to the negative control animals which received an IP injection of physiological saline.

Executive summary:

A 0.2 g/ml solution of test material FC911 (nickel containing dust). was injected into 5 mice via the intraperitoneal route at a dose of 1 ml/20g body weight. This concentration had no effect on the animals when compared to the negative control animals which received an IP injection of physiological saline. This study (Coronati, 2009) is considered reliable (2), it is a non-GLP, guideline study, available as an unpublished report with minor restrictions in design and/or reporting, but it is otherwise adequate for assessment.