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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:
10.-14.10.2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Feb. 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Jan. 1997.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium fuer Landwirtschaft, Umweltschutz und Raumordnung, Land Brandenburg, Potsdam

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Chbb:IIM(SPF) - Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight animals: 2.4 kg bw
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe; ad libitum.
- Water: free access to domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C
- Humidity: 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): cycle of 12 hours light and 12 hours darkness. Light: 6 a.m. to 6 p.m..

DATES:
The experimental work was carried out between 10.10.2000 and 14.10.2000.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: yes, the untreated eye of the rabbit served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL
- Concentration: undiluted
Duration of treatment / exposure:
Single exposure, no rinsing.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- no rinsing

SCORING SYSTEM: See 'Any other information on materials and methods'

TOOL USED TO ASSESS SCORE:
After the first 24h reading, flurescein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution the eyes were examined again using UV-light to detect possible corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3, #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal: #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
One hour after application of the test article animals No. 1926 and No. 1928 showed some conjunctival vessels definitely injected and a discharge different from normal. In animal No. 1929 some conjunctival vessels definitely injected were observed and a discharge with moistening of the lids and hairs just adjacent to lids. Animal No. 1930 showed some conjunctival vessels definitely injected, a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids.

24 hours after application of the test article animals No. 1928 and No. 1929 had some conjunctival vessels definitely injected. In animal No. 1930 were observed some conjunctival vessels definitely injected and a swelling above normal. The animal No. 1926 was free of any signs of eye irritation.

48 hours and 72 hours after application of the test article all four animals No. 1926, No. 1928, No. 1929 and No. 1930 were free of any signs of eye irritation.

Any other information on results incl. tables

Scores for ocular lesions:

*Individual mean score: Only the scores from the readings after 24, 48 and 72 hours are included in the

calculation of the individual mean scores.

 Rabbit No/Weight per kg  Parameter  Individual mean score*
 1926/2.4  cornea opacity  0.00
   iris  0.00
   conjunctiva redness  0.00
   conjunctiva chemosis  0.00
 1928/2.4  cornea opacity  0.00
   iris  0.00
   conjunctiva redness  0.33
   conjunctiva chemosis  0.00
 1929/2.4  cornea opacity  0.00
   iris  0.00
   conjunctiva redness  0.33
   conjunctiva chemosis  0.00
 1930/2.4  cornea opacity  0.00
   iris  0.00
   conjunctiva redness  0.33
   conjunctiva chemosis  0.33

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The test item is not to be classified as eye irritating according to CLP regulation.
Executive summary:

In the current study the eye irritant effects of the test item were investigated according to the method recommended in the OECD Guideline No. 405, and EEC Guideline B.5. The study was performed in accordance with GLP.

Four female albino rabbits were exposed to 0.1 mL of the test article in one eye, while the other eye remained untreated and served as control. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing.

Only very slight signs of irritation were observed on the treated eyes. Compared to the classification criteria indicated in the CLP regulation, the test item shall not be classified as eye irritating.