Neodymium trichloride

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

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

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)
- 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

Administration / exposure

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.

Results and discussion

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.

Effect levels

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

Applicant's summary and conclusion

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.