Neodymium trichloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Directive 79/831 de la C.E.E –annexe V partie B

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Neodymium trichloride

EC Number:

233-031-5

EC Name:

Neodymium trichloride

Cas Number:

10024-93-8

Molecular formula:

Cl3Nd

IUPAC Name:

neodymium trichloride

Test material form:

solid

Details on test material:

- Appearance: Red

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 200 g (males), 140 to 180 g (females)
- Fasting period before study: Animals were subjected to a water diet from 17 to 19 hours before the treatment until three hours after treatment.
- Housing: plastic cages (36.5 x 22.5 x 18.0 cm) containing sterilised sawdust
- Diet: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1.5 °C
- Humidity: 55 ± 15 %
- Air changes: 10 per hour

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

Administration
- Doses: 3980, 5000, 5620 and 6300 mg/kg (Main test)
- Administrtaion volume: 10 mL/kg
- Rationale for the selection of the starting dose: Results of the preliminary study

Doses:

Preliminary study: 1000, 2500 and 5000 mg/kg
Main study: 3980, 5000, 5620 and 6300 mg/kg

No. of animals per sex per dose:

5 animals per sex per dose (Main study)
2 animals per sed per dose (Preliminary study)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behavior and mortality were observed after the administration of the test material then 1 hour, 2 hours, 4 hours after and every day for 14 days. Body weighing was performed at -1, 0, 7 and 14 days and at the death of the animal if it has survived more than 24 hours.
- Necropsy of survivors performed: yes autopsy was performed on animals found dead or sacrificed at the end of the observation period.

Statistics:

No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Preliminary study:

A preliminary study was performed on 2 males and 2 females at 1000, 2500 and 5000 mg/kg bw. During the preliminary study no mortality was observed at 1000 and 2500 mg/kg but 50 % mortality was seen at 5000 mg/kg.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 068 mg/kg bw

Based on:

test mat.

Remarks on result:

other: estimated value

Mortality:

1 female dosed at 3980 mg/kg died on day 1, 2 males at the same dose level died on day 2.
All of the males dosed at 5000 mg/kg survived, 2 females died on day 1 and a further female died on day 4.
In the 5620 mg/kg dose group, 2 males died on day 4 with a third male dying on day 7. 2 females of the same dose group died on day 1.
In the 6300 mg/kg dose group, 1 male died on day 2, a further 2 males died on day 4 and a further male died on day 7. 3 females of the same dose group died on day 1, a further female died on day 7.

Clinical signs:

other: Clinical signs recorded during the study period included ataxia, piloerection, and ptosis with abdominal distension occurring at the higher doses. At the end of the 14-day observation period, the surviving animals treated at 5620 mg/kg had not all recover

Gross pathology:

- Necropsic examinations were performed on dead animals during the observation period or sacrificed at the end of the observation period. The abdominal and thoracic cavities were opened and a gross necropsy was performed.
- Animals that died during the observation period: For most animals and at all doses: A dilatation of the non-glandular part of the stomach, a necrotic aspect of the glandular part, as well as discolouration or necrosis of all the organs in contact with the stomach.
- In animals sacrificed at the end of the observation period: In most animals, induration of the glandular wall of the stomach was seen.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the oral LD50 value in Sprague-Dawley rats was estimated to be 5068 mg/kg.

Executive summary:

The potential of the test material to cause acute toxicity via the oral route was determined in accordance with OECD guideline no. 401 and under GLP conditions using male and female Sprague-Dawley rats.

Five male and five female rats were exposed to an oral dose of test maerial at 3980, 5000, 5620 and 6300 mg/kg. Rats received a 10 mL/kg dose in the vehicle of water. A control group were dosed water only.

30 % mortality was observed at 3980 and 5000 mg/kg, 50 % mortality was seen at 5620 mg/kg and 90 % mortality was seen at 6300 mg/kg. There was no mortality observed in the vehicle control group. Observations during the study period included a depression with ataxia, piloerection, ptosis and at high dose levels, an inflated abdomen.

The following abnormalities were seen during the autopsy of animals that died during the study period: dilatation of the non-glandular part of the stomach, a necrotic aspect of the glandular part and discoloration or necrosis of all the organs in contact with the stomac. In the animals sacrificed at the end of the observation period induration of the glandular wall of the stomach was seen in most animals. The effects on the stomach are irritant/ corrosive effects due to the effects of H+ and not due to neodymium.

Under the conditions of this study, the oral LD50 value of the test material in Sprague-Dawley rats was estimated to be 5068 mg/kg.