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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-12-7 to 1998-12-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-290-0
EC Name:
-
Cas Number:
3380-30-1
Molecular formula:
C12 H8 Cl2 O2
IUPAC Name:
5-chloro-2-(4-chlorophenoxy)phenol
Details on test material:
- Name of test material (as cited in study report): FAT 80'220/A
- Physical state: solid, powder
- Analytical purity: >99 %
- Lot/batch No.: GRU 98
- Expiration date of the lot/batch: 2008-10-31
- Stability under test conditions: stability of test item in bidistilled water not specified.
- Storage condition of test material: in the original container at room temperature (approx. 20°C) away from direct sunlight; the test item was stable under storage conditions.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Weight at study initiation: 2913 g (female), 3200 g (female), 2890 g (male)
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3410 rabbit maintenance diet ad libitum
- Water: Community tap water from Itingen, ad libitum, in water bowls
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 40- 70 %
- Air changes (per hr): 10 - 15 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served for control
Amount / concentration applied:
On the day of treatment, approximately 0.1 g of unchanged test item was placed into the conjunctival sac of the left eye of each animal; the lids were then gently held together for about one second to prevent loss of test article. The treated eyes were not rinsed after application.
Duration of treatment / exposure:
The treated eyes were not rinsed after application.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 animals
Details on study design:
READING
Reading of the eye was done at 1, 24, 48 and 72 hours, as well as at day 7, 14 and 21 post application.

SCORING SYSTEM
The ocular reaction was assessed according to the numerical scoring system recommended by the guideline and was based on the Draize scoring system. When present, corrosion and/or staining of sclera and cornea by the test item were recorded.

TOOL USED FOR EXAMINATION
Varta Cliptrix diagnostic-lamp (A. Riegger, Basel/Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: the animal showed no corneal opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Corneal opacity graded 1 was seen until day 21 of observation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Corneal opacity graded 1 was seen until day 7 of observation
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no effects in the iris were seen.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no effects in the iris were seen.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no effects in the iris were seen.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Redness of the conjunctivae graded 1 was seen at time point 1 hour. Redness was graded 2 at 24, 48 and 72 hours, and turned back to grade 1 at day 7. Thereafter, the finding was no more evident.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Redness of the conjunctivae graded 1 was seen at all considered time points and still was evident at day 21.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Redness of the conjunctivae graded 1 was seen at time point 1 hour and became more severe thereafter, reaching grade 2 at 24, 48 and 72 hours, respectively. From day 7 to 21, redness graded 1 still was evident.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Chemosis appeared at time point 24 hours and was graded 3. Chemosis graded 2 and 1 was seen at 48 and 72 hours, respectively. At time point 7 days, the finding was no more evident.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Chemosis graded 1 was seen from time point 1 hour until time point 7 days and was no more evident thereafter.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Chemosis was graded 2 at time point 1 hour, 3 at 24 hours, 2 at 48 hours and 1 at 72 hours. Chemosis graded 1 lasted until day 7 and was no more evident thereafter.
Irritant / corrosive response data:
In all animals, reddening (including hyperemia of the scleral blood vessels) and swelling of the conjunctivae, swelling of the nictitating membrane, as well as watery discharge was observed. In two animals, slight opacity and mucous discharge was evident. Hyperemia of the scleral blood vessels persisted in all animals until the end of the observation period. In two animals, conjunctival redness and in one animal, opacity was noted until 21 days after treatment.
Other effects:
No staining of the treated eyes by the test item was observed.
No signs indicating corrosion were observed at any of the reading time points.
Neither mortality nor clinical signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
other: The test item causes severe damage to the eye; according to current evaluation criteria, the test item is to be classified - Xi, R41 according to EU Directive 67/548/EC and Cat 1 according to the CLP Regulation 1272/2008.