Neodymium trifluoride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not reported

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

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:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neodymium trifluoride

EC Number:

237-253-3

EC Name:

Neodymium trifluoride

Cas Number:

13709-42-7

Molecular formula:

F3Nd

IUPAC Name:

neodymium trifluoride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Appearance: pink powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Sprague-Dawley OFA (IOPS)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation (prior to fasting): 160 - 200 g (males); 140 - 180 g (females)
- Fasting period before study: no
- Housing: animals were individually housed in plastic cages (375 x 170 x 150 mm) containing a sterilised and vacuum-cleaned sawdust litter
- Food consumption: ad libitum
- Water consumption: ad libitum
- Acclimation period: data not available

ENVIRONMENTAL CONDITIONS:
- Temperature: 22 ± 1.5 °C
- Humidity: 55 ± 15 %
- Air changes: 10 per hour
- Photoperiod: data not available

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 10 % aqueous dispersion of gum arabic

Details on dermal exposure:

-The test material was applied to the shaved laterodorsal area of the back. It was administered in the 10 % aqueous dispersion of gum Arabic at a dose volume of 5 mL/kg and a concentration of 40 g/mL.
-The test material was covered by foil and secured with tape.
-After 24 hours, the dressing was removed and the treated area rinsed with warm water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: after application, then 1, 2 and 4 hours; daily from day 1 to day 14
> weighing: one day before treatment, and on days 0, 7 and 14 after treatment
>cutaneous condition was noted from day 1 onwards
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

Mortality checks were performed at 1, 2, 4 hours, and then on days 1, 2, 4, 7 and 14.
No mortality was observed.

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No abnormalities, erythema or oedema were observed.

Gross pathology:

No gross abnormalities were observed at necropsy.

Other findings:

No mortalities in the preliminary test.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD0 (males and females) was >2000 mg/kg bw and therefore the test material is not classified based on the results of this study in accordance with EU criteria.

Executive summary:

An acute dermal toxicity limit test was conducted to assess the test material in accordance with the standardised guidelines OECD 402 and EU Method B.3.

Groups of 6 - 7 week old Sprague-Dawley rats (5 per sex) were exposed to a single 2000 mg/kg dermal dose of the test material in a 10 % aqueous solution of gum arabic. The test material was applied to the shaved laterodorsal area and the site covered in foil secured with tape. After 24 hours, the dressing was removed and the site rinsed with water. Animals were observed for 14 days.

No mortality and no clinical signs were observed during the study. No gross abnormalities were observed at necropsy.

The dermal LD0 (males and females) was >2000 mg/kg and therefore the test material is not classified for acute dermal toxicity based on the results of this study in accordance with EU criteria.