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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report. Test procedure according to national standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: FEDERAL REGISTER 38, NO. 187, PARA. 1500.42, 5. 27029; 27.09.73
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellol
EC Number:
203-375-0
EC Name:
Citronellol
Cas Number:
106-22-9
Molecular formula:
C10H20O
IUPAC Name:
3,7-dimethyloct-6-en-1-ol
Details on test material:
- Name of test material (as cited in study report): Citronellol
- Substance No.: 78/741

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: female
- Weight at study initiation: mean 2.57 kg (2.33 - 3.15 kg)
- Diet: SSNIFF sold by Intermast

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye untreated, serves as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
application into the conjunctival sac of the lower right eyelid
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:

turgor/swelling of conjunctiva or opacity of cornea:
0 = nonexistant
1 = slight
2 = distinct
3 = intense
4 = severe

affected area of cornea:
1 = 0 < A < 1/4
2 = 1/4 <= A < 1/2
3 = 1/2 <= A < 3/4
4 = 3/4 <= A

redness of conjunctiva:
0 = regular
1 = slightly increased
2 = distinct
3 = intense

secretion:
0 = regular
1 = slightly increased
2 = distinctly increased
3 = highly increased

iris:
1 = ciliary injection
2 = iritia

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
30.5
Max. score:
39
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0.28
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.72
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.44
Max. score:
4
Reversibility:
fully reversible within: 8 days
Other effects:
- scars in all animals
- suppuration in one animal
- pupil contraction in one animal

Any other information on results incl. tables

Results:

 cornea      iris conjunctiva     calculated irritation scores    
time animal opacity area redness turgor/swelling secretion other cornea iris conjunctiva total mean
24 h 1 1 4 0 2 2 2 scar 20 0 12 32 33,67
2 1 4 0 2 2 2 scar 20 0 12 32
3 1 4 1 2 2 2 scar 20 5 12 37
4 1 4 0 2 2 2 scar 20 0 12 32
5 1 4 1 2 2 2 scar 20 5 12 37
6 1 4 0 2 2 2 scar 20 0 12 32
48 h 1 1 4 0 1 1 1 scar 20 0 6 26 29,00
2 1 4 0 2 2 2 scar 20 0 12 32
3 1 4 1 2 2 3 scar/suppuration 20 5 14 39
4 1 4 0 2 1 1 scar 20 0 8 28
5 1 3 0 1 1 1 scar 15 0 6 21
6 1 4 0 2 1 1 scar/pupil contraction 20 0 8 28
72 h 1 1 4 0 1 1 1 scar 20 0 6 26 28,83
2 1 4 1 2 1 2 scar 20 5 10 35
3 1 4 1 2 2 3 scar/suppuration 20 5 14 39
4 1 4 0 1 0 1 scar 20 0 4 24
5 1 3 0 1 1 1 scar 15 0 6 21
6 1 4 0 2 1 1 scar/pupil contraction 20 0 8 28
8 d 1 0 0 0 0 0 0 scar 0 0 0 0 5,17
2 1 1 0 2 0 1 scar 5 0 6 11
3 0 0 0 1 0 1 scar 0 0 4 4
4 1 1 0 1 0 0 scar 5 0 2 7
5 1 1 0 1 0 0 scar 5 0 2 7
6 0 0 0 1 0 0 scar 0 0 2 2
Mean 24-72 h 1 1.0 4.0 0.0 1.3 1.3 1.3 20.0 0.0 8.0 28.0
2 1.0 4.0 0.3 2.0 1.7 2.0 20.0 1.7 11.3 33.0
3 1.0 4.0 1.0 2.0 2.0 2.7 20.0 5.0 13.3 38.3
4 1.0 4.0 0.0 1.7 1.0 1.3 20.0 0.0 8.0 28.0
5 1.0 3.3 0.3 1.3 1.3 1.3 16.7 1.7 8.0 26.3
6 1.0 4.0 0.0 2.0 1.3 1.3 20.0 0.0 9.3 29.3
Mean 24-72 h 1 3.89 0.28 1.72 1.44 1.67 19.4 1.4 9.7 30.5

24h after application of 0,1 ml of test substance:
slight opacity of complete cornea and in 2/6 cases ciliary injections; 
all animals: distinct redness and turgor/swelling of conjunctiva, increased secretion  of tears and scarred retractions at the eyelid

72h: 
redness and turgor of conjunctiva and secretion in regression

8d: 
3/6 animals show very light opacity of small areas of cornea, 
5/6  show slight redness of conjunctiva, 
2/6 show slightly increased secretion of tears, 
1/6 shows temporary suppuration, 
1/6 shows temporary  contraction of the pupil; 
all animals: irreversible scarred alterations of the eyelid
primary irritation score: 31 -> moderately irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating acc. to EU criteria, but irritating acc. GHS criteria due to iris-scores >= 1.