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Diss Factsheets

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:
30 October - 08 November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,2-trifluoro-1-{5,8,14-triazatetracyclo[10.3.1.0²,¹¹.0⁴,⁹]hexadeca-2,4,6,8,10-pentaen-14-yl}ethan-1-one
EC Number:
810-682-9
Cas Number:
230615-70-0
Molecular formula:
C15H12F3N3O
IUPAC Name:
2,2,2-trifluoro-1-{5,8,14-triazatetracyclo[10.3.1.0²,¹¹.0⁴,⁹]hexadeca-2,4,6,8,10-pentaen-14-yl}ethan-1-one
Test material form:
solid: particulate/powder
Details on test material:
Buff coloured solid or pale brown powder depending on which batch
Storage conditions: room temperature. in the dark
Specific details on test material used for the study:
Buff coloured solid
Storage conditions: room temperature in the dark
Batch number: 53650-10-11

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White rabbits at the start of the study the animals were in the weight range of 2.63 to 3.00 kg
and were twelve to sixteen weeks old. After an acclimatisation period of at least five days each
animal was given a number unique within the study which was written with a black indelible
marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking
water and food (Certified Rabbit Diet (Code 5322) supplied by PMI Nutrition International,
Nottingham. UK) was allowed throughout the study. The diet and drinking water were
considered not to contain any contaminant of a level that might have affected the purpose or
integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70%
respectively. Any occasional deviations from these targets were considered not to have affected
the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per
hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00
to 18:00) and twelve hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
A volume of 0.1 ml of the test material, which was found to weigh approximately 60 mg (as measured by gently compacting the required volume into an
adapted syringe) was placed into the conjunctival sac of the right eye formed by gently pulling the lower lid away from the eyeball.
Duration of treatment / exposure:
The upper and lower eyelids were held together for about one 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. Immediately after administration of the test material. an assessment of the initial pain reaction was made according to the six point scale.After consideration of the ocular responses produced in the first treated animal. two additional animals were treated.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 2, 48, and 72 hours following treatment according to a numerical evaluation. Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. An additional observation was made on Day 7 to assess the reversibility of the ocular effects.
Details on study design:
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


At the end of the study one animal (number 25) was humanely killed and two animals (numbers 97 and 102) were transferred to the pyrogen colony.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 25 Male
Time point:
other: 1 hr.
Score:
10
Max. score:
22
Irritation parameter:
overall irritation score
Basis:
animal: 25 Male
Time point:
24 h
Score:
22
Max. score:
22
Irritation parameter:
overall irritation score
Basis:
animal: 25 Male
Time point:
48 h
Score:
13
Max. score:
22
Irritation parameter:
overall irritation score
Basis:
animal: 25 Male
Time point:
72 h
Score:
2
Max. score:
22
Irritation parameter:
overall irritation score
Basis:
animal: 25 Male
Time point:
7 d
Score:
0
Max. score:
22
Irritation parameter:
overall irritation score
Basis:
animal: 97 Female
Time point:
other: 1 hr.
Score:
17
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 97 Female
Time point:
24 h
Score:
6
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 97 Female
Time point:
48 h
Score:
0
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 97 Female
Time point:
72 h
Score:
0
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 97 Female
Time point:
7 d
Score:
0
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 102 Male
Time point:
other: 1 hr.
Score:
17
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 102 Male
Time point:
24 h
Score:
13
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 102 Male
Time point:
48 h
Score:
4
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 102 Male
Time point:
72 h
Score:
0
Max. score:
17
Irritation parameter:
overall irritation score
Basis:
animal: 102 Male
Time point:
7 d
Score:
0
Max. score:
17
Irritant / corrosive response data:
Effects were fully reversible within 7 days.

Any other information on results incl. tables

Iridial inflammation was noted in two treated eyes at the 1-hour observation, and persisted in one treated eye and developed in one other treated eye at the 24-hour observation. No other iridial effects were noted.

Moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal to moderate conjunctival irritation at the 24-hour observation. Minimal to moderate conjunctival irritation was noted in two treated eyes at the 48-hour observation. Minimal conjunctival redness persisted in one treated eye at the 72-hour observation. Residual test material was noted in all treated eyes at the 1-hour observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CP-548,507 produced a maximum group mean score of 14.7 and was classified as a MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
Executive summary:

The test material did not meet the criteria for classification as irritant according, to EU labelling regulations Commission Directive 93 /21/EEC and does not meet the GHS criteria.