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:
2006
Report Date:
2006

Materials and methods

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

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
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 3.0-3.1 kg
- Housing: individual
- Diet: approx. 100 g per animal per day
- 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:
other: the opposite eye (untreated) of each animal served as control
Amount / concentration applied:
Amount applied: 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours after the 24-hr exposure period
Number of animals or in vitro replicates:
3 (females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): only in animal 1 eye was rinsed with 0.9 % saline solution after 24 hours since test compound adhered to conjunctiva and cornea

SCORING SYSTEM: according to DRAIZE


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 24, 48 and 72 hours: 0.0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 24, 48 and 72 hours: 0.0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score after 24, 48 and 72 hours: 1.0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: mean score after 24, 48 and 72 hours: 0.0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: mean score after 24, 48 and 72 hours: 0.0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean score after 24, 48 and 72 hours: 0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: # 2,3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 24, 48 and 72 hours: 0.0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
Further observations:
Animal 1, 1 h p.a.: test compound adhered to cornea and conjunctiva,
24 h p.a.: test compound adhered to conjunctiva and cornea, eye was rinsed with 0.9 % saline solution
Animal 2, 1 h p.a.: test compound adhered to cornea and conjunctiva,
Animal 3, 1 h p.a.: test compound adhered to cornea and conjunctiva.

No systemic intolerance reactions were observed.


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not irritating to the eyes.
Conclusions:
The test material was not irritating to the eyes of rabbits according to OECD TG 405. No systemic intolerance reactions were observed.
Executive summary:

In an eye irritation test the test material meeting the form described in Section 4.5 of the IUCLID dossier was not irritating to the eyes of rabbits according to OECD TG 405. No systemic intolerance reactions were observed.