Neodymium trichloride

Endpoint summary

Description of key information

Acute oral toxicity on test material

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.

Acute dermal toxicity

Under the conditions of this study no mortality was observed at 2000 mg/kg.

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:

July 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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

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).

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 068 mg/kg bw

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:

June 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

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
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 200 g (males), 140 to 180 g (females)
- Housing: Animals kept individually in plastic cages (37.5 x 17.0 x 15.0 cm) containing sterilised sawdust
- Diet: ad libitum

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

Type of coverage:

occlusive

Vehicle:

water

Remarks:

sterile

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area
- Type of wrap if used: aluminium foil secured by a bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours of application, the dressing was removed, the treated zone was then rinsed with lukewarm water.

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg at 5 mL/kg
- Concentration: 40 g/100 mL

Duration of exposure:

24 hours

Doses:

1

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Behaviour and mortality were observed immediately after the application of the test material and then 1 hour, 2 hours, 4 hours after and every day for 14 days. Body weight measurements was performed at 0, 7 and 14 days and at the death of the animal if it has survived more than 24 hours. Skin irritation was observed on day 1 and every day thereafter.

- Necropsy of survivors performed: yes autopsy was performed on animals found dead or sacrificed at the end of the observation period.

Preliminary study:

A preliminary study was performed on 2 males and 2 females at 1000 and 2000 mg/kg. During the preliminary study no mortality was observed and as a result 2000 mg/kg was used for the main study.

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the 14 day period.

Clinical signs:

other: Daily observation of the animals for 14 days did not reveal any abnormalities attributable to treatment with the test material.

Gross pathology:

No macroscopically detectable abnormalities were observed at gross necropsy.

Other findings:

- Skin irritation at the test site:
Erythema was noted in all animals at day 1

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study no mortality was observed at 2000 mg/kg.

Executive summary:

The potential toxicity of the test material via the dermal route was investigated under GLP conditions, using male and female rats in a 14 day long study.

Following a preliminary study which tested 1000 and 2000 mg/kg dose levels and saw no mortality the main study was conducted using 2000 mg/kg. Five male and five female rats were treated with the test material spread over the clipped dorsal area wrapped inaluminium foil secured by a band of plaster. The rats were exposed to the treatment for 24 hours before it was removed and washed with lukewarm water. Animals were observed for 14 days following treatment.

Under the conditions of this study none of the animals died prematurely, there were no clinical signs that could be attributed to treatment with the test material and all animals gained weight during the study. Erythema was noted at the test site in all animals at day 1.No macroscopically detectable abnormalities were observed at gross necropsy.

The LD50 was therefore determined to be in excess of 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity

The potential of the test material to cause acute toxicity via the oral route was determined following a method which was comparable to that which is outlined in the standardised guideline OECD 401. The study was conducted under GLP conditions using male and female Sprague-Dawley rats. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

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.

Acute dermal toxicity

The potential toxicity of the test material via the dermal route was investigated under GLP conditions, using male and female rats in a 14 day long study. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

Following a preliminary study which tested 1000 and 2000 mg/kg dose levels and saw no mortality the main study was conducte using 2000 mg/kg. Five male and five female rats were treated with the test material spread over the clipped dorsal area wrapped inaluminium foil secured by a band of plaster. The rats were exposed to the treatment for 24 hours before it was removed and washed with lukewarm water. Animals were observed for 14 days following treatment.

Under the conditions of this study none of the animals died prematurely, there were no clinical signs that could be attributed to treatment with the test material and all animals gained weight during the study. Erythema was noted at the test site in all animals at day 1. No macroscopically detectable abnormalities were observed at gross necropsy.

The LD50 was therefore determined to be in excess of 2000 mg/kg bw.

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 via the oral and dermal routes.