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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:
28 Jul - 04 Aug 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2020
Deviations:
yes
Remarks:
no analgesic applied prior to, during or after test item instillation
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
adopted in 1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales, Düsseldorf, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (Rettenmaier & Söhne GmbH & Co, Rosenberg, Germany)
- Diet: Ssniff K-Z 4mm (Ssniff Spezialdiäten GmbH, Soest, Germany), approximately 100 g per animal per day
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, 72 hours and Day 7
Duration of post- treatment incubation (in vitro):
Not applicable
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
The eye was rinsed 24 h after test item instillation

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
One hour following test substance instillation, the test compound adhered to cornea and conjunctivae. The test item caused conjunctival redness and chemosis in all 3 animals. Scores for conjunctival redness were 2/2/1/1 in 2/3 animals and 2/2/2/2 in 1/3 animals 1, 24, 48 and 72 h after instillation. Scores for conjunctival chemosis were 2/1/0/0 in 1/3 animals, 2/2/0/0 in 1/3 animals and 1/2/2/1 in 1/3 animals 1, 24, 48 and 72 h after instillation. All effects were fully reversible by study Day 7.
Other effects:
No clinical signs of systemic toxicity were observed.

Any other information on results incl. tables

Table 1: Eye irritation effects

Animal No. 1
Observation 1 h 24 h 48 h 72 h Day 7 Day 14 Day 21 Score 24/48/72 h
Degree of corneal opacity 0 0 0 0 0 - - 0
Area of corneal opacity 0 0 0 0 0 - -
Iris 0 0 0 0 0 - - 0
Conjunctival redness 2 2 1 1 0 - - 1.33
Conjunctival chemosis 2 1 0 0 0 - - 0.33
Animal No. 2
Observation 1 h 24 h 48 h 72 h Day 7 Day 14 Day 21
Degree of corneal opacity 0 0 0 0 0 - - 0
Area of corneal opacity 0 0 0 0 0 - -
Iris 0 0 0 0 0 - - 0
Conjunctival redness 2 2 1 1 0 - - 1.33
Conjunctival chemosis 2 2 0 0 0 - - 0.67
Animal No. 3
Observation 1 h 24 h 48 h 72 h Day 7 Day 14 Day 21
Degree of corneal opacity 0 0 0 0 0 - - 0
Area of corneal opacity 0 0 0 0 0 - -
Iris 0 0 0 0 0 - - 0
Conjunctival redness 2 2 2 2 0 - - 2.00
Conjunctival chemosis 1 2 2 1 0 - - 1.67

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 substance was tested for eye irritation/ corrosion according to OECD guideline 405. For the treated eyes of all 3 rabbits used in the test, conjunctival redness and chemosis were noticed, with the effects being reversible within 7 days. However, Draize scoring values remained below the limits for classification, and thus, the substance is considered not to be an eye irritant.