Registration Dossier

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: OECD GUIDELINE, GLP STUDY

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
• Identification, reference : UG - batch 97302300
• Appearance white solid (pieces)
• Quantity received, packaging: 100 g, plastic box
• Date ofreceipt : November 10, 1997
• Laboratory reference: 97-3691
• Analytical sheet flot supplied
• Homogeneity test flot required for less than 28 days studies
• Storage: at room temperature, away from the light and heat

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Species, strain, supplier : New-zealand albino rabbit, Charles RIVER (76110 Saint Aubin Les Elbeuf France).
Reason for species selection the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities.
- Number and sex 3 females
If strong eyes effects are foreseeable, the test is performed in one animal. From the results obtained, the test may be flot realized in the two others.
- Average weight: 2.4 kg
- Identification: auricular ring
- Acclimatization : at least 5 days
- Housing, diet : environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individual housing on floor grid). Complete pelleted rabbit maintenance diet ERG]LAP Anco, COFNA (37018 - TOURS, FRANCE).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye as control
Amount / concentration applied:
100 mg
Observation period (in vivo):
after 1h, 24h, 48h and 72 hour,up to 21 days
Number of animals or in vitro replicates:
3
Details on study design:
After checking that the rabbit has healthy, defect-free eyes, the test material is placed at a dose of 0.1 ml or 0.1 g if test substance is pasty or solid in the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball.
The lids are then gently held together for about one second in order to prevent loss of the material.
The other eye, which remains untreated, serves as a control.
Afler a one hour period of contention, the animal is returned to its individual cage.
In this study, the test substance is used as such at the dose of 0.1 mI/eye (after pounding it in a mortar).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Max. score:
2
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the 67/548/EEC order classification, the substance UG batch 97302300 should be considered as irritant to eyes (with formation of important ocular iesions).
Executive summary:

The instillation of the substance UG - batch 97302300 at the dose of 0.1 ml into the eye of three rabbits, produced one hour after instillation, in ail the animals, the outbreak of diffuse purple enanthemae with important lacrimations and chemosis. A congestion ofthe iris was also noted in the 3 animals and a slight and partial opacification of the cornea was found in two of them.

24 hours afier instillation, these reactions were maintained and severe cornea lesions werc evidenced in the three rabbits. A pannus noted on the cornea of two rabbits on D9 was maintained till D19 for one of them and D21 for the second one. The reversibility of the ocular reactions was flot complete at the end ofthe 21-day-observation period in two of the animals.

According to the 67/548/EEC order classification the substance UG batch 97302300 is classified among the substances irritating to eyes (with important ocular iesions).