Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to GLP requirements and EU method.
Cross-reference
Reason / purpose:
reference to other 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:
Cited as Directive 84/449/EEC, B.5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): AHTN (Tonalid)
- Physical state: pure solid substance

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy male young adult albino rabbits. Body weight range 2500g - 3500g obtained from ENKI konijnenfarm, Someren, The Netherlands. The animals were identified by ear marking. Animals were caged individually and did not receive hay or other extraneous material that might enter their eyes during treatment.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Amount applied: 0.1 gram
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
168 hours post application
Number of animals or in vitro replicates:
3
Details on study design:
A sample of tonalid was examined for eye irritating properties in an experiment with albino rabbits. An aliquot of 0.1 g test material was instilled in 1 eye of 3 male New Zealand White albino rabbits with no further treatment (also not rinsed). The untreated eye served as a control. The eyes were examined at 1, 24, 48 and 72 hours and at 7, 14 and 21 days if reactions persisted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 168 hours.
Remarks on result:
other: individual means: 1-1-0
Irritation parameter:
iris score
Remarks:
opacity
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: individual means: 0.67-0-0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
1.44
Max. score:
3
Reversibility:
fully reversible within: 29 days
Remarks on result:
other: individual means: 1.67-1.67-1
Irritation parameter:
chemosis score
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
1.22
Max. score:
4
Reversibility:
fully reversible within: 168 hours
Remarks on result:
other: individual means: 1.67-1-1

Any other information on results incl. tables

Individual scores for 3 animals from an eye irritation test with AHTN

Time point Cornea Iris Conjunctivae Conjunctivae
after opacity   Redness chemosis
1 hour 0-0-0 0-0-1 2-1-2 2-1-2
24 hours 1-1-0 1-0-0 2-2-1 2-1-1
48 hours 1-1-0 1-0-0 2-2-1 2-1-1
72 hours 1-1-0 0-0-0 1-1-1 1-1-1
7 days 0-0-0 0-0-0 0-1-1 0-0-0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The cornea, iris, conjunctivae and chemosis scores were sufficiently assessed and the effects were fully reversible, except for some remaining redness in the conjunctivae after 7 days in 2 of the 3 animals. No effects were seen after 29 days.
Executive summary:

AHTN (Tonalid®; purity >98%) was applied undiluted as a finely ground powder (0.1 g) to the eyes of 3 New Zealand White albino rabbits. The test substance remained in the eyes for at least 24 hours. Eye irritation was evaluated at 1, 24, 48, 72 and 168 hour post application. Two rabbits had slight corneal opacity at 24-72 hr. Slight iritis was observed in one animal at the 1 hour observation and in another animal at the 24 and 48 hour observations. A slight (1/3 animals) to moderate (2/3 animals) redness and slight (2/3) to moderate (1/3 animals) swelling of the conjunctivae was seen after 24-48 hour. After 7 days a slight redness of the conjunctivae without any other effects was still seen in two animals. All effects had cleared by 29 days.

Source: EU risk asssessment AHTN, Luxembourg, Office for Official Publications of the European Communities, ECB May 2008, p. 179