Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 8 jul 1985 to 19 aug 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to the standardised method but no data about GLP.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
version 19.9.84 and accordind OECD guideline
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- Species: rabbit
- Strain: New Zealand White
- Source: Charles River : F 76410 - Saint-Aubin-lès-Elbeuf ; E.G.A.V. : Saint-Mars-d'Egrenne - F 61350 - Passais-la-Conception ; Elevage Scientifique des Dombes : Roman - F 01400 - Chatillonsur-Chalaronne.
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (± 200 g)
- Housing : The rabbits are kept in individual polystyrene cages, measuring 540 x 360 x 315 mm with a perforated polystyrene floor in a ventilated and air conditioned room. Lighting is artificial for 12 hours per day (7.30 a.m. - 7.30 p.m.).
- Diet : 150 g of complete maintenance food (granulés Lapin Entretien "112" UAR, 91360 - Villemoisson / Orge) is provided per rabbit and per day.
- Water :ad libitum automatically (softened and filtered water : 15 µ)
- Acclimation period: at least 8 days. Animals were vaccinated against the Myxomatosis (Lyomyxovax, Institut Mérieux).

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

IN-LIFE DATES: application date: 23 july 1985

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye of animal
Amount / concentration applied:
- Test material:
Amount applied: 0.1 ml
pH: 4.2
- Vehicle: none
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
- Removal of test system: Washing (if done) and Time after start of exposure.
The eyes of 3 rabbits are washed out 4 seconds after the installation, care being taken not to cause injury, and on the 3 other animals 30 seconds
after the application of the test substance. About 50 ml of the rinsing solution (boric acid 1.8g, sodium borate 1.2 g, sodium chloride 0.3 g, phenyl
mercury borate 0.002g rose distilled water qsp 100 ml) at about 20°C is administered using a plastic jet at moderate pressure.
The control eye is washed out under the same conditions as the treated one. The excess of liquid is immediately wiped away with a codex hydrophilic gauze pad.

- Scoring system: EU
For examination of the eyes, the animals are immobilized on a table, and both eyes are comparatively examined. Examination was made by
comparison with the control eye 1 hour after instillation, and then 24, 48 and 72 hours later. If the 3 days observation is insufficient for fully
evaluating the reversibility or the irreversibility of the lesions observed, it can be prolonged 7, 14 and 21 days.

- Tool used to assess score: Observation of the condition of the cornea is made with the aid of a Heine's ophtalmoscope (Miroflex). This
ophtalmoscope may also be used to observe the iris, pupil and lens.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2 - 4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Mean at 24, 48 and 72 hours: 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Mean at 24, 48 and 72 hours: 1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2 - 3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Mean at 24, 48 and 72 hours: 2.34
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1 - 2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Mean at 24, 48 and 72 hours: 1.5
Irritant / corrosive response data:
- Overall irritation score: Chemosis: 2.34; Conjonctiva: 1.5; Iris: 1;  Cornea: 2
Other effects:
corneal ulceration, cyanose reversible within 2 days.

Any other information on results incl. tables

Eye irritation score table:

Score at time point / Reversibility Cornea Iris Conjunctivae Chemosis
Max. score: 4 Max. score: 2 Max. score: 3 Max. score: 4
60 min 2/2/2/2/2/2 1/1/1/1/1/1 1/1/1/1/2/1 2/2/2/2/2/2
24 h 2/2/2/2/2/2 1/1/1/1/1/1 2/2/1/1/2/1 3/3/3/2/2/3
48 h 2/2/2/2/2/2 1/1/1/1/1/1 2/2/1/1/2/1 2/3/2/2/2/2
72 h 2/2/2/2/2/2 1/1/1/1/1/1 2/2/1/1/2/1 2/3/2/2/2/2
Average 24h, 48h, 72h for all animals 2/2/2 1/1/1 1.5/1.5/1.5 2.67/2.17/2.17
Reversibility* n n n n

n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Xi R41 Criteria used for interpretation of results: EU
Conclusions:
According to 1985 EU criteria substance was considered as irritant for the eyes.
Considering 2006 EU criteria, as the observation period was only 72 hours without reversibility effect observed, and considering that for all the
animals corneal opacity is >1, iris lesion=1 and chemosis >=2, the substance is considered as highly irritating for the eyes.
- Criteria used for interpretation of results: the interpretation of examination was made according to criteria of directive 79/831.

Classification: risk of serious damage to eyes
Classification according to CLP criteria: Eye damage Cat. 1 H318 (Causes serious eye damages)
Executive summary:

In a primary eye irritation study (Hazleton, 1985), 0.1 ml of undiluted paratrifluoromethylaniline (>98.5) was instilled into the conjunctival sac of one eye of 6 New Zealand White rabbits. Animals then were observed for 3 days. Irritation was scored by the method according to criteria of directive EC 67/548.
After 72 hours, the overall irritation was Chemosis:
2.34;Conjonctiva: 1.5; Iris: 1; Cornea: 2, were not fully reversible within 72 h.
Based on this study, p-trifluoromethylaniline (>=98.5%) is considered severely irritating to the eye and was classified XI R41 according to the Annex VI of the directive 67/548/EC, and Eye damage Cat. 1 H318 according to the CLP criteria.