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Diss Factsheets

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:
guideline study
Justification for type of information:
The in vivo test was performed before the REACH regulation came into force, requesting in vitro studies. This information is used for read-across to Citronellyl Acetate Multi
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across information
Justification for type of information:
The read-across justification is presented in the Endpoint summary Irritation. The accompanying files are also attached there.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: read-across from Citronellyl Acetate ('mono')
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: read-across from Citronellyl Acetate ('mono')
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: read-across from Citronellyl Acetate ('mono')
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: read-across from Citronellyl Acetate ('mono')
Interpretation of results:
other: Not an eye irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments.
Conclusions:
The substance is not considered an eye irritant based on adequate information of one its key constituents.

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellyl acetate
EC Number:
205-775-0
EC Name:
Citronellyl acetate
Cas Number:
150-84-5
Molecular formula:
C12H22O2
IUPAC Name:
3,7-dimethyloct-6-en-1-yl acetate
Test material form:
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:
other: untreated eye of same animal
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
Number of animals or in vitro replicates:
3
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)

SCORING SYSTEM:
-according to OECD guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

For calculation of the means of opacity, iris, redness and swelling, the 24, 48 and 72 hours readings were taken into consideration.

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:
other: Not an eye irritant.
Remarks:
according to EU CLP (EC No. 1272/2008, and its amendments).
Conclusions:
The scores for cornea opacity, conjunctiva effects (redness, swelling or discharge) and iris effects were 0 at all time-points for all rabbits. Based on these results, it is concluded that Citronellyl acetate (mono) has no eye irritant effects.
Executive summary:

An in vivo eye study was performed with Citronellyl Acetate (‘mono’) according to OECD guideline 405 and following GLP principles. Three rabbits received a single instillation of 0.1 mL in the conjunctival sac of their right eyelid. No washing as performed, animals were observed at one hour after instillation and after 24, 48 and 72 hours. The scores for cornea opacity, conjunctiva effects (redness, swelling or discharge) and iris effects were 0 at all time-points for all rabbits. Based on these results, it is concluded that Citronellyl acetate (mono) has no eye irritant effects.