Neodymium trichloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 April 1984 to 10 May 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 April 1984 to 14 April 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot No.of test material: 83040

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 kg ± 200 g
- Housing: individually housed in polystyrene cages (540 x 360 x 315 mm) with a perforated polystyrene floor
- Diet: 150 g per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 to 70%
- Air changes: 12 to 14 times per hour
- Photoperiod: 12 hours lighting per day, 7.30 am to 7.30 pm

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the patch

Number of animals:

6

Details on study design:

METHOD
The day before the application of the test material, the backs and flanks of six rabbits were clipped free of fur with an electric clipper, to expose a surface of 14 x 14 cm. Only animals with perfectly healthy intact skin showing no macroscopic sign of irritation, after a rest period of 24 hours were used for the study.
0.5 g of the test material was moistened with water and applied directly onto the animal skin and spread evenly over an area of ca. 6 cm² and then covered with a gauze pad about 2.5 cm².
The test material and gauze pad were held in contact with the skin with a semi-occlusive patch: 10 cm wide adhesive perforated tape applied on a crimped gauze bandage covering the whole clipped surface and wrapped around the animal.
The test material was kept in contact with the skin for 4 hours whilst the animals were kept in plastic restraining boxes.
After the exposure treatment the bandages were removed and if necessary any excess test material wiped from the skin with a gauze pad moistened with deionised water.
The cutaneous irritation was evaluated 1, 24, 48 and 72 hours after removal of the test material.

DESCRIPTION OF REACTIONS
Erythema and Eschar formation:
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 = No oedema
1 = Very slight oedema (barely perceptible)
2 = Slight oedema (edges of area well defined by definite raising)
3 = Moderate oedema (edges raised approximately 1 mm)
4 = Severe oedema (raised more than 1 mm and extending beyond the area of exposure)

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Very slight erythema was noted in one of the six treated animals at 1, 24, 48 and 72 hours following removal of the test material.

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study the test material was determined to be non-irritating to the skin.

Executive summary:

The potential of the test material to cause irritation to the skin was determined in accordance with the standardised guideline OECD 404 using an in-vivo method.

During the study, six male New Zealand White rabbits were treated with the test material under a semi-occlusive dressing for four hours. After the removal of the test material the skin was observed at 1, 24, 48 and 72 hours for cutaneous irritation.

Very slight erythema was observed in 1 out of 6 animals but no oedema was observed.

Under the conditions of this study the test material was determined to be non-irritating to the skin.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

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

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot No.of test material: 83040

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 kg ± 200 g
- Housing: individually housed in polystyrene cages (540 x 360 x 315 mm) with a perforated polystyrene floor
- Diet: 150 g per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 to 70%
- Air changes: 12 to 14 times per hour
- Photoperiod: 12 hours lighting per day, 7.30 am to 7.30 pm

Test system

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

The eyelids were held together for ten seconds to avoid any loss of test material. The animals were then restrained for one hour.

Observation period (in vivo):

1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation

Number of animals or in vitro replicates:

6

Details on study design:

Any animals showing possible ocular lesions were eliminated from the study. 100 mg of the test material was placed into the conjunctival sac of the right eye of the animal, the upper and lower eyelids are held together for ten seconds to avoid the loss of any test material. The left eye served as a control. Each animal was immobilised in a plastic restraining box during treatment and for one hour afterwards.

Animals were immobilised for examination, the examinations were always carried out under the same conditions (especially lighting) and the treated eye was compared to the control at 1, 24, 48 and 72 hours post treatment and again at 7, 14 and 21 days after treatment

Observations of the cornea was made with the aid of a Heine's ophthalmoscope which was also used to observe the iris, pupil and lens, if required. If further examination was necesarry a slit lamp was used.

Observations were made on the following: conjunctivae (oedema and redness), pupil, iris congestion, corneal lesions and opacity degree.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2.28

Max. score:

3

Reversibility:

not fully reversible within:

Remarks:

21 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within:

Remarks:

21 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

21 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within:

Remarks:

21 days

Applicant's summary and conclusion

Interpretation of results:

other: Irreversible effects on the eye (Category 1) in accordance with EU criteria

Conclusions:

Under the conditions of the study the test material requires classification for irreversible effects on the eye (Category 1).

Executive summary:

The potential of the test material to cause irritation to the eye was determined in accordance with the standardised guideline OECD 405 using an in-vivo method.

Six male New Zealand White rabbits were treated with the test material which was placed into the conjunctival sac of the right eye of the animal, the upper and lower eyelids are held together for ten seconds to avoid the loss of any test material. The left eye served as a control. The eye was observed at 1, 24, 48 and 72 hours and at days 7, 14 and 21 for signs of ocular irritation.

Chemosis and conjunctival redness were observed in the treated eyes of all animals from 1 hour post-treatment and the effects were not reversible within the 21-day observation period. Iridial effects (score 1) were noted in all animals at all timepoints. Corneal opacity was observed in the treated eyes of all animals from 24 hours post-treatment and the effects were not reversible within the 21-day observation period.

Therefore, under the conditions of the study the test material requires classification for irreversible effects on the eye (Category 1).