Neodymium trifluoride

Endpoint summary

Description of key information

Skin Irritation
The test substance is not irritating to the skin of rabbits.
Eye Irritation
The test substance is not irritating to the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 April 1984 - 6 June 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted 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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Albino New Zealand
- Sex: males
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: individual housing, in polystyrene cages, of internal dimensions 540 x 360 x 315 mm, with a perforated floor
- Diet: 150 g of complete maintenance food per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 12 to 14 times per hour (pre-filtered air: 5 - 10 µ)
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 18 April 1984 To: data not available

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g of the test material was applied as a paste with 0.06 mL of water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: a surface of about 6 cm²
- % coverage: no data
- Type of wrap: semiocclusive dressing: covered with a Codex hydrophilic eight layer gauze pad 2.5 cm per side, followed by 10 cm wide adhesive perforated tape (Peloplast: M.S.R.) applied on a crimped gauze bandage (Creplux-Molinier) covering more particularly the whole clipped surface (to avoid possible orthoergic reactions) and wrapped around the animal (without blocking the respiratory and abdominal movements).


REMOVAL OF TEST SUBSTANCE
- Washing: the bandages were removed and if necessary excess test material, which had not penetrated, was wiped away with a gauze pad moistened with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Erythema and eschar formation:

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4

Oedema formation:

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

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritation effects observed

Other effects:

The pink colour of the test material made the observation of erythema imprecise. The surplus of the test material which did not penetrate the skin was removed with a gauze compress that had been soaked with water. The initial reading was taken 1 hour later.

Table 1: Summary of Erythema Scores

Animal Number	Mean Score over 24, 48 and 72 hours
1	0
2	0
3	0
4	0
5	0
6	0
Mean	0

 

Table 2: Summary of Oedema Scores

Animal Number	Mean Score over 24, 48 and 72 hours
1	0
2	0
3	0
4	0
5	0
6	0
Mean	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to this study, the test material is not classified as a dermal irritant.

Executive summary:

A dermal irritation study was conducted in accordance with the standardised guideline OECD 404.

Six male New Zealand White rabbits were dermally exposed to 0.5 g of the test material moistened with 0.06 mL of water to form a paste. Test sites were covered with a semi-occlusive dressing for 4 hours, followed by observation of the animals for 72 hours. Irritation was evaluated based on erythema and oedema reactions observed 1, 24, 48 and 72 hours after the end of application.

No skin reactions were observed during the study. The mean score for the readings at 24, 48 and 72 hours for both erythema and oedema was equal to 0.

Under the conditions of this study, the test material is not classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 April 1984 - 6 June 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted 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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Albino New Zealand
- Sex: males
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: individual housing, in polystyrene cages, of dimensions 540 x 360 x 315 mm, with a perforated floor
- Diet: 150 g of complete maintenance food per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 12 to 14 times per hour (pre-filtered air: 5 - 10 µ)
- Photoperiod: 12 hrs dark / 12 hrs light

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye remained untreated and served as control

Amount / concentration applied:

Amount applied: 0.1 g in the right eye.

Duration of treatment / exposure:

The upper and lower eyelid are held together for 10 seconds to avoid loss of test substance.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
no washing

TOOL USED TO ASSESS SCORE: Heine's ophthalmoscope / fluorescein

SCORING SYSTEM: Draize

1. CONJUNCTIVAE

Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal............................................................................................................................................0
Vessels definitely injected above normal................................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible....................................2
Diffuse beefy red.........................................................................................................................................3

Chemosis
No swelling..................................................................................................................................................0
Any swelling above normal (includes nictitating membrane).............................................................1
Obvious swelling with partial eversion of lids.......................................................................................2
Swelling with lids about half closed.........................................................................................................3
Swelling with lids half closed to completely closed...............................................................................4

Discharge
No discharge...............................................................................................................................................0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)......................................................................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids...............................................2
Discharge with moistening of the lids and hairs a considerable area around the eye...................3

IRIS

Values
Normal.........................................................................................................................................................0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive).................................................................................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)....................................2

CORNEA

Degree of Opacity (most dense area used)
No opacity...................................................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible......................................................................1
Easily discernible translucent areas, details of iris slightly obscured..............................................2
Opalescent areas, no details of iris visible, size of pupil barely discernible....................................3
Opaque, iris not discernible through the opacity................................................................................4

Area of Cornea Involved
One quarter (or less) but not zero..........................................................................................................1
Greater than one quarter but less than half...........................................................................................2
Greater than half but less than three quarters......................................................................................3
Greater than three quarters, up to whole area.......................................................................................4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean of 24, 48 and 72 hours

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean of 24, 48 and 72 hours

Score:

0.06

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Very minor effects seen in some animals at 24 and 48 hour time points. No scores observed were greater than 1 at any time point in any animal.
At the 24 hour time point, Chemosis observed in 3/6 animals, conjunciveal irritation in 2/6 animals and iris irritation in 1/6 animals. At 48 hours, chemosis was observed in one animal. No other effects observed in any other animals at ay time points.

Table 1: Individual Results

Time Point (hours)	Rabbit Number	Chemosis	Conjunctivae	Iris	Cornea
24	856 857 858 859 860 861	1 0 0 1 1 0	1 1 0 0 0 0	0 0 0 0 1* 0	0 0 0 0 0 0
48	856 857 858 859 860 861	0 0 0 0 1 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0
72	856 857 858 859 860 861	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0	0 0 0 0 0 0

*Circumcorneal injection

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to this study, the test material is not classified as an eye irritant.

Executive summary:

An eye irritation study was conducted in accordance with the standardised guideline OECD 405. 0.1 g of the test material was instilled into the conjunctival sac of the right eye of six male New Zealand white rabbits.

Ocular irritation was scored based on chemosis and changes to the iris, cornea and conjunctivae at 24, 48 and 72 h.

The mean scores for the 6 rabbits across all time points were 0 for corneal opacity, 0.06 for iritis, 0 for redness and 0.22 for chemosis of the conjunctivae.

In this study, the test material was seen to be not irritating to the eye, requiring no classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

The key study was conducted in accordance with the standardised guideline OECD 404.

Six male New Zealand White rabbits were dermally exposed to 0.5 g of the test material moistened with 0.06 mL of water to form a paste. Test sites were covered with a semi-occlusive dressing for 4 hours, followed by observation of the animals for 72 hours. Irritation was evaluated based on erythema and oedema reactions observed 24, 48 and 72 hours after the end of application.

No skin reactions were observed during the study. The mean score for the readings at 24, 48 and 72 hours for both erythema and oedema was equal to 0.

Under the conditions of this study, the test material is not classified.

 

Supporting information is provided in the form of a second study that followed the FHSA 16 CFR 1500.41 guideline. This study was awarded a reliability score of 2 in accordance with the criteria of Klimisch (1997).

Six New Zealand White rabbits were dermally exposed to 0.5 g of the test material on one intact and one abraded skin site. Test sites were covered with an occlusive dressing for 24 hours. The patches were then removed and the test sites wiped to prevent further exposure. Evaluation occurred 24 and 72 hours after exposure.

With the exception of one intact site with very slight erythema at 24 hours, all sites were clear of irritation during the test period.

Under the conditions of this study, the test material is not irritating to skin and requires no classification.

 

Eye Irritation

The key eye irritation study was conducted in accordance with the standardised guideline OECD 405. 0.1 g of the test material was instilled into the conjunctival sac of the right eye of six male New Zealand white rabbits.

Ocular irritation was scored based on chemosis and changes to the iris, cornea and conjunctivae at 24, 48 and 72 h.

The mean scores for the 6 rabbits across all time points were 0 for corneal opacity, 0.06 for iritis, 0 for redness and 0.22 for chemosis of the conjunctivae.

In this study, the test material was seen to be not irritating to the eye, requiring no classification.

 

Supporting information is provided in the form of second study conducted in accordance with FHSA guideline 16 CFR 1500.42. This study was awarded a reliability score of 1 in accordance with the criteria of Klimisch (1997).

0.1 g of the test material was instilled into the right eye of six New Zealand white rabbits, with three of the treated eyes being rinsed after 30 seconds with saline. The animals were observed for three days and the eyes examined at 24, 48 and 72 hours. Irritation was scored according to the method of Draize.

The test material produced minimal irritation to both the unwashed and washed eyes and no classification is required under the conditions of this study.

Justification for selection of skin irritation / corrosion endpoint:
The key study was conducted in accordance with the standardised guideline OECD 404. It was well reported and adhered to sound scientific principles. It was awarded a reliability score of 1 in accordance with the criteria of Klimisch (1997).

Justification for selection of eye irritation endpoint:
The key study was conducted in accordance with the standardised guideline OECD 405. It was well reported and adhered to sound scientific principles. It was awarded a reliability score of 1 in accordance with the criteria of Klimisch (1997).

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for irritation or corrosion to either the skin or eye.