Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-04-19 to 2000-06-23
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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:
- form: solid
- storage: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste– F40260 Linxe). They were kept during a minimal 6-day acclimatisation period. During the test, the animals weighed between 1.95 kg and 2.45 kg.

The environmental conditions were:
- temperature : between 19°C and 22°C
- relative humidity : between 39% and 54%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3
Details on study design:
- 3 rabbits
- 0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment. Evaluation of chemosis, redness of the conjunctivae, iris lesion and cornea opacity.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
11.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: D1
Score:
21.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: D2
Score:
10.7
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: D3
Score:
5.7
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: D4
Score:
4.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: D5
Score:
2
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: D6
Score:
1.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: D7
Score:
0
Irritant / corrosive response data:
The ocular reactions observed, at the level of each treated eyes were slight to moderate with a rapid reversibility:
- slight to moderate conjunctivae reaction (enanthema, lachrymation and chemosis) recorded 1 hour after the test product instillation and totally reversible between the 7th and 8th day of the test,
- slight to moderate corneal reaction were noted for 2 animals 24 hours after the test product instillation and totally reversible between the 4th and the 6th day of the test.
Average irritation index:
D0 1 hour : 11.3
D1: 21.3
D2: 10.7
D3: 5.7
D4: 4.3
D5: 2.0
D6: 1.3
D7: 0.0

Applicant's summary and conclusion

Interpretation of results:
moderately 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 item:
- is moderately irritant for the eye (Max. O.I = 21.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, need not to 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.
Executive summary:

The test substance was instilled, into the eye of three New Zealand rabbits at the dose of 0.1 g. The experimental protocol was 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 dated December 29th 1992.

The ocular reactions observed, at the level of each treated eyes were slight to moderate with a rapid reversibility: - slight to moderate conjunctivae reaction (enanthema, lachrymation and chemosis) recorded 1 hour after the test product instillation and totally reversible between the 7th and 8th day of the test, - slight to moderate corneal reaction were noted for 2 animals 24 hours after the test product instillation and totally reversible between the 4th and the 6th day of the test.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test substance:

- is moderately irritant for the eye (Max. O.I = 21.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.

- and, need not to 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.