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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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Designation: CITRONELLYL ACETATE EXTRA
Appearance: colourless to pale yellowish liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adults
- Animal identification: ear tattoo
- Weight at study initiation: females 3.60 kg, 3.96 kg; male 3.98 kg
- Housing: single housing, stainless stell wire mesh cages with grating, floor area: 3000 cm2
- Bedding: no bedding in the cages; sawdust in the waste trays
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: tap water (about 250 ml/animal/day)
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml in single application to conjunctival sac of right eyelid
Duration of treatment / exposure:
once continously
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

GENERAL OBSERVATIONS
- check for dead or moribund animals: twice daily (Mo - Fr), once daily (Sa/Su)

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: 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: 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: 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: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
see table 1.

Any other information on results incl. tables

Table 1: Irritant response data:

Readings Animal cornea Iris conjunctiva Symptoms
opacity area redness swelling discharge
1 h 1 0 0 0 1 0 2  -
2 0 0 0 1 0 1
3 0 0 0 1 0 1  -
24 h 1 0 0 0 0 0 0
2 0 0 0 0 0 0
3 0 0 0 0 0 0
48 h 1 0 0 0 0 0 0
2 0 0 0 0 0 0  -
3 0 0 0 0 0 0  -
72 h 1 0 0 0 0 0 0  -
2 0 0 0 0 0 0  -
3 0 0 0 0 0 0  -
Mean 24 - 72 h 1 0 0 0 0 0 0
2 0 0 0 0 0 0
3 0 0 0 0 0 0
Mean   0 0 0 0 0 0  

Animal 1: female; animal 2: female; animal 3: male

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not found to be irritant to the eye when tested in vivo on rabbits.