Registration Dossier

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:
12 Apr - 28 Apr 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to the OECD TG 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Designation as given in study report: Albinos Hy/Cr, derived from NZW
- Source: Elevage Charles River France, Saint Aubin-lès-Elbeuf, France
- Weight at study initiation: 2 - 3.5 kg
- Housing: individually in stainless steel cages
- Diet: UAR 112 diet pellets (Société UAR, Epinay-sur-Orge, France), 150 g per animal and day
- Water: tap water, ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye served for control
Amount / concentration applied:
The test article was applied undiluted at an amount of 0.1 mL into the conjunctival sac of the right eye of each animal. The lids were then gently held together for about one second to prevent loss of the test article.
Duration of treatment / exposure:
The treated eyes were not rinsed; the first examination was done one hour after instillation of the test article in the conjunctival sac.
Observation period (in vivo):
72 hours
Reading time points: 1, 24, 48 and 72 hours after application

Number of animals or in vitro replicates:
Three male animals
Details on study design:
The irritation was assessed according to the OECD guideline and the findings were scored as recommended by the guideline, according to the numerical Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2 and 3, respectively
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed corneal opacity due to treatment
Irritation parameter:
iris score
Basis:
animal: 1, 2 and 3, respectively
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed effects in the iris due to treatment
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: conjunctival redness grade 1 was reported for this animal after 1, 24 and 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: conjunctival redness grade 1 was reported for this animal after 1 and 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: conjunctival redness grade 1 was reported for this animal after 1 and 24 h
Irritation parameter:
chemosis score
Basis:
animal: 1, 2 and 3, respectively
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed chemosis due to treatment
Irritant / corrosive response data:
After 1 and 24 hour following application all 3 animals displayed conjunctival redness grade 1. At reading time point 48 h, reversibility was achieved in 2 cases whereas the third animal still showed conjunctival redness grade 1. At reading time point 72 h, reversibility was also achieved in the third animal. No further effects were seen.
Other effects:
Neither toxic symptoms nor mortality were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified