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

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Retinol 50 C, a technical preparation of retinol (CAS-No. 68-26-8);
content of the active substance was 47.7 g/100 g (analytical report no. 99C04293).
Physical state / appearance : At storage conditions : solid / yellow; After heating at approx. 50°C: liquid, oil / yellow
Storage conditions : In a refrigerator, exclusion of light and oxygen (stored under nitrogen)
Batch No. : 50-2498
Date of production : November 15, 2001

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lage, Vonnas (France)
- Age at study initiation: 4-5 months 
- Weight at study initiation: 3.33-3.48 kg
- Water: ad libitum
- Housing: Single housing in wire mesh cages with grating, floor area: 3000 square cm
- Diet: about 130 g/animal per day (Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left eye of each rabbit served as control.
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
The eyes were scored at 1 hour, 24, 48, 72 hours, and  8 days after instillation.
Number of animals or in vitro replicates:
3 (2 males, 1 female)
Details on study design:
One tenth millilitre of the unchanged, liquid test material (i.e. a ca. 50% solution of retinol; no data on solvent and/or contaminants) was  instilled into the conjunctival sac of the right eye of each of three New  Zealand white rabbits. The test material was washed out (rinsed) with tap water about 24 hours after instillation. 

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Table: Individual Draize scores for cornea (opacity, area involved),  iris, and 

conjunctivae (redness, chemosis, discharge) and additional  findings

animal   cornea     iris   conjunctivae           add. 
no       op. area          redn.  chem.  disc.    find.
---------------------------------------------------------
1-hour reading
1        0   0      0      3      2       2       DB, 48
2        0   0      0      3      2       2
3        0   0      0      3      2       2
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1        0   0      0      3      2       3       DB, 48
2        0   0      0      3      3       0       49
3        0   0      0      3      2       2       49
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1        0   0      0      3      1       0       48
2        0   0      0      2      1       0       48
3        0   0      0      2      1       0       48
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1        0   0      0      2      1       0       48
2        0   0      0      1      1       0       48
3        0   0      0      2      1       0       48
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
7-day-reading
1        0   0      0      0      0       0
2        0   0      0      0      0       0
3        0   0      0      0      0       0
---------------------------------------------------------
individual mean scores
1        0.0        0.0    2.7    1.3
2        0.0        0.0    2.0    1.7
3        0.0        0.0    2.3    1.3
---------------------------------------------------------
total mean score (mean of 3)
         0.0        0.0    2.3    1.4
---------------------------------------------------------
codes used for additional findings:
DB = discharge of blood
48 = scleral vessels injected, circumscribed area
49 = scleral vessels injected, circular

Applicant's summary and conclusion