Indium phosphide

Endpoint summary

Description of key information

An acute oral toxicity study was performed on Indium Phosphide according to a method similar to the OECD TG 420.

Four-week-old Male ICR mice (SPF grade) were given a single dose of 0, 1,000, 3,000 or 5,000 mg/kg bw of Indium Phosphide (99.999% Purity) as a powder in physiological saline solution.

Following the exposure observations of behaviour, body weight and external appearance were made for two weeks. Ensuing the observation period, the mice were sacrificed and their blood was collected for analysis, and their kidneys, lungs, spleen, liver and testes were all observed and weighed. Indium concentrations observed in organs were compared to those of the control and higher dose groups.

No mice died due to oral exposure to Indium Phosphide. No changes in external appearance, behaviour and body weights among the groups were observed. Traces of indium phosphide were detected in the serum, liver and kidneys, however no clear increases of the weight of these organs were recorded. A decrease of the blood urea nitrogen proportionate to the increased exposure concentration was noted. Finally, colour change on the lung surface of numerous mice were observed.

Considering that Indium Phosphide has a LD50 > 5,000 mg/kg bw, it does not meet the criteria for classification according to Regulation 1272/2008.

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:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

highested dose investigated and number of animals used not in accordance with OECD TG 420.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

no

Species:

mouse

Strain:

ICR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nippon SLC
- Age at study initiation: 4 weeks
- Weight at study initiation: Not reported
- Fasting period before study: No
- Housing: Plastic cage
- Diet : Pelleted rodent chow (ad libitum)
- Water: Distilled water (ad libitum)
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24
- Humidity (%): 60%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light

Route of administration:

oral: unspecified

Vehicle:

physiological saline

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0, 1,000, 3,000, or 5,000 mg/kg of InP particles suspended in 0.3 ml of physiological

MAXIMUM DOSE VOLUME APPLIED: 5,000 mg/kg

Doses:

0, 1,000, 3,000, or 5,000mg/kg

No. of animals per sex per dose:

3 males at 0 mg/kg, 9 males at 1,000 mg/kg, 9 males at 3,000 mg/kg and 6 males at 5,000 mg/kg.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behaviour and external apperance every weekday. Bodyweight every other day.
- Necropsy of survivors performed: yes
- Other examinations performed: The lungs, liver,kidneys, spleen, and testes were carefully observed, removed and weighed. Additionally blood analysis and serum indium concentrations were measured.

Statistics:

Student's t- test or Welch's method were used to establish the difference between the means of the effect indices. Fischer's test was used for the analysis of pathological findings.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No Mice died during the two week observation period.

Clinical signs:

other: No clear changes in behaviour or external apperance were found.

Gross pathology:

Colour change of the lung surface observed.

Other findings:

- Organ weights: There was no clear tendency in increase of the lung, spleen or kidney weight
- Potential target organs: Lungs
- Other observations: Traces of Indium phosphide detected in the serum, kidneys and liver. Blood urea nitrogen decreased proportionate to the increase in exposure concentration.

Interpretation of results:

GHS criteria not met

Conclusions:

Following an acute oral toxicity experiment in mice, it was determined that Indium Phosphide was not acutely toxic via the oral route under the conditions of the study. No mortality was observed at the highest dose over a 14-day period, rendering an LD50 > 5,000 mg/kg bw. The substance does not meet the criteria for classification according to Regulation 1272/2008.

Executive summary:

An acute oral toxicity study was performed on Indium Phosphide according to a method similar to the OECD TG 420.

Four-week-old Male ICR mice (SPF grade) were given a single dose of 0, 1,000, 3,000 or 5,000 mg/kg bw of Indium Phosphide (99.999% Purity) as a powder in physiological saline solution.

Following the exposure observations of behaviour, body weight and external appearance were made for two weeks. Ensuing the observation period, the mice were sacrificed and their blood was collected for analysis, and their kidneys, lungs, spleen, liver and testes were all observed and weighed. Indium concentrations observed in organs were compared to those of the control and higher dose groups.

No mice died due to oral exposure to Indium Phosphide. No changes in external appearance, behaviour and body weights among the groups were observed. Traces of indium phosphide were detected in the serum, liver and kidneys, however no clear increases of the weight of these organs were recorded. A decrease of the blood urea nitrogen proportionate to the increased exposure concentration was noted. Finally, colour change on the lung surface of numerous mice were observed.

Considering that Indium Phosphide has a LD50 > 5,000 mg/kg bw, it does not meet the criteria for classification according to Regulation 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The acute toxicity of Indium Phosphide via the oral route was evaluated using a method similar to OECD guideline 420 (Fixed dose procedure) without any significant deviations.

Justification for classification or non-classification

This study determined the LDL0 of indium phosphide following oral administration to male mice to be >5,000mg/kg. The LD50 could not be calculated in this study therefore based on these results, it can be concluded that the LD50 of indium phosphide is >5000mg/kg and therefore the substance will be classified as a GHS category 5 substance.