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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:
2007-12-11 to 2008-03-03
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid, pearl
- Analytical purity: 100%
- Lot/batch No.: T71225
- Expiration date of the lot/batch: 21 March 2009 (re-test)
- Storage condition of test material: at the room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste –F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the animals weighed between 2.91 kg and 3.33 kg. At the beginning of the test, the animals were 13 to 14-
week old.
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 19°C and 21°C
- relative humidity : between 41% and 67%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely. Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D3, two additional animals were treated.
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
- 1 hour after instillation: total score = 22, average irritation index = 7.3
- 24 hours after instillation: total score = 2, average irritation index = 0.7
- 48 hours after instillation: total score = 0, average irritation index = 0
- 72 hours after instillation: total score = 0, average irritation index = 0

Maximal ocular irritation index (MAX OI) = 7.3

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test substance:
- is slightly irritant for the eye (Max. O.I = 7.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, 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, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 “irritating to eyes”. No signal word and hazard statement are required.
Executive summary:

The test substance was instilled after being reduced in fine powder, at the dose of 0.1 g into the eye of three New Zealand rabbits. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC. The ocular conjunctivae reactions observed during the study have been slight and totally reversible in the three animals: a slight redness, noted 1 hour after the test item instillation and totally reversible between D1 and D2, associated with a slight chemosis only noted 1 hour after the test item instillation. In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test substance 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° 67/548,2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test substance must not be classified in category 2 “irritating to eyes”. No signal word and hazard statement are required.