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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:
07 Jul - 01 Aug 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2012)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino (Zika)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kaninchenbetrieb Kock, Warnkenhagen, Germany
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: 2980 and 3210 g
- Housing: the test animals were housed individually in cages.
- Diet: conventional laboratory diet (a half-and-half blend of "Holstenstolz Kaninchenverbrauchsfutter 2, Type 038" [Wilhelm Stroeh jr. GmbH & Co. KG, Germany] and "Rabbit maintenance, MuesliMash", [ssniff Spezialdiäten GmbH, Germany], ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Single application
Observation period (in vivo):
8 days
Reading time points: 1, 24, 48 and 72 h and 8 days
Number of animals or in vitro replicates:
2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The solid test substance had not been removed from the eye of the test animals by physiological mechanisms at the first observation time point after treatment, therefore the eyes were rinsed with physiological saline.
- Time after start of exposure: 1h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight conjunctival redness and chemosis (grade 1) were observed in 2/2 animals 1 h post-application of the test material, which were fully reversible within 24 h. No effects on cornea and iris were recorded. One animal was further observed for up to 8 days, which showed no effects in the treated eye.
Other effects:
No further local or systemic effects and no effects on body weight gain were observed during the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified