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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 June 2010 to 10 June 2010
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:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Description: extremely pale purple powder
Batch No.: not supplied
Date received: 15 Feb 2010
Expiry date: 15 Feb 2011
Storage conditions: room temperature in the dark over silica gel
pH: 10% aqueous solution = 6.0 immediately after preparation and 5.9 10 minutes after

The integrity of supplied data relating to the identiy, purity, and stability of the test material was repsonsibility of sponsor.
Test material was used as supplied.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, UK Ltd., Loughbourough, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.25-2.26 kg
- Housing: 1 per cage; suspended cages
- Diet: ad libitum, 2030 Teklad Global diet supplied by Harlan Laboratories UK, Oxon UK
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr):at least 15 apr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
69 mg by gently compacting the required volume (0.1mL) into an adapted syringe
Duration of treatment / exposure:
Throughout observation period
Observation period (in vivo):
1, 24, 48, and 72 h following treatment
Number of animals or in vitro replicates:
2
Details on study design:
PROCEDURE
Eyes of test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. A volume of 0.1 ml of the test material (69 mg) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for ~1 second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Pain reaction and assessment of ocular damage evaluations were performed as noted below. After consideration of ocular responses, a second animal was treated in the same manner. Other ocular effects and clinical effects were noted; individual bodyweights recorded on day 0 and at the end of the observation period.

INTERPRETATION OF RESULTS.
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C (1962), J. Soc. Cosmet. Chem. 13, 281 289 (see Appendix 3) was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material.
If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 96 hour time points
Score:
0
Max. score:
0
Reversibility:
other: N/A
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 96 hour time points
Score:
0
Max. score:
0
Reversibility:
other: N/A
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 and 96 hour time points
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 and 96 hour time points
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Other effects:
Initial pain reaction was slight after 1 hr (3/3) reduced to pratically no pain at 24 h (1/1) and beyond in one animal. The other animal had continued slight pain through 24 h (2/3) to pratically no pain (2/3) or no pain (1/3) at 48 h, clear by 72 h.

No changes in body weight were observed.

Any other information on results incl. tables

Table1            Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex

69282Male

69959Male

IPR= 2

IPR = 3

Time After Treatment

1
Hour

24
Hours

48
Hours

72
Hours

1
Hour

24
Hours

48
Hours

72
Hours

CORNEA

 

 

 

 

 

 

 

 

E = Degree of Opacity

0

0

0

0

0

0

0

0

F = Area of Cornea Involved

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

IRIS

 

 

 

 

 

 

 

 

D

0

0

0

0

0

0

0

0

Score (D x 5)

0

0

0

0

0

0

0

0

CONJUNCTIVAE

 

 

 

 

 

 

 

 

A = Redness

2

1

0

0

2

2

1

0

B = Chemosis

2

1

0

0

2

2

1

0

C = Discharge

2

1

0

0

2

1

0

0

Score (A + B + C) x 2

12

6

0

0

12

10

4

0

Total Score

12

6

0

0

12

10

4

0

IPR= Initial pain reaction

Table2            Individual Total Scores and Group Mean Scores for Ocular Irritation

Rabbit Number

and Sex

Individual Total Scores At:

1 Hour

24 Hours

48 Hours

72 Hours

69282Male

12

6

0

0

69959Male

12

10

4

0

Group Total

24

16

4

0

Group Mean Score

12.0

8.0

2.0

0.0

 

Table3            Individual Bodyweights and Bodyweight Changes

Rabbit Number
and Sex

Individual Bodyweight (kg)

Bodyweight Change (kg)

Day 0

Day 3

69282Male

2.26

2.31

0.05

69959Male

2.25

2.30

0.05

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dineodymium trichloride was found not to be iirritating to the eyes of New Zealand rabbits.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following: OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” and Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008

Dineodymium trichloride was found not to be irritating to the eyes of New Zealand rabbits.