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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OCDE guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2001-04-18

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Container : plastic tube (n=2) • Form : thick liquid
• Quantity : 118.80g (Container + Content) • Colour : yellow - brown
• Batch : 4359 MP • Storage: room temperature
It was identified under the code number : PH-01/0148.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three female albinos rabbits, numbered A4008, A4009 and A4010 of new-Zealand strain, originating
from the Elevage de Gérome (Quartier Labaste – F40260 Linxe) were kept during a 6-day
acclimatisation period. During the test, the animals weighed between 2.29kg and 2.45kg.
Animals were kept in individuals boxes, the environmental conditions were :
- temperature : between 19 °C and 23 °C
- relative humidity : between 49% and 63%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
1hour, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3
Details on study design:
A volume of 0.1 ml of the pure test product was instilled into one eye of each rabbit, the other eye
untreated serving as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 4 days

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
- is slightly irritant for the eye (Max. O.I = 9.3) according to the classification established in the
Journal Officiel de la République Française dated July 10th, 1992.
- must not be classified according to the criteria for the classification, packaging and labelling of
dangerous substances in compliance with the E.E.C. Directive n° 67/548 and 93/21.
Executive summary:

The product LCA01006 was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 ml, according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated February 24th, 1987 and the test method B.5 of the directive 92/69/E.E.C. dated December 29th, 1992.

The ocular reactions observed during the study remained slight and only recorded at the conjunctivae level: redness 1 hour after the test product instillation and totally reversible between the 3rd and the 4th day of the test, associated with a slight chemosis in the 3 animals on examination time 1 hour only.

In conclusion, the result obtained, enable to conclude that the test product LCA01006:

- is slightly irritant for the eye (Max. O.I = 9.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.

- must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548 and 93/21.