Registration Dossier
Registration Dossier
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EC number: 203-376-6 | CAS number: 106-23-0
Eye irritation
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: Study comparable to guideline study with minor restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- post-observation limited to 8 days, no scores after 1 hr exposure
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187, § 1500.42, p. 27029 from 27.09.73
- GLP compliance:
- no
Test material
- Reference substance name:
- Citronellal
- EC Number:
- 203-376-6
- EC Name:
- Citronellal
- Cas Number:
- 106-23-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethyloct-6-enal
- Details on test material:
- - Name of test material (as cited in study report): Citronellal; CAS 106-23-0; substance number 78/742
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Weight at study initiation (mean): male: 2.68 kg; female 2.71 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated or saline treated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- single
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.
CHEMOSIS AND CORNEA OPACITY- DEGREE OF DENSITY:
0= NONE
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
4 = VERY SEVERE
Cornea area:
1 = >0; < ¼
2 = ≥ ¼; < ½;
3 = ≥ ½; < ¾;
4 = ≥ ¾;
IRIS:
1 = CIRCUM-CORNEAL INJECTION
2 = IRITIS
CONJUNCTIVAE REDNESS:
0 = NORMAL
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
DISCHARGE:
0 = NORMAL
1 = SLIGHTLY INCREASED
2 = CLEARLY INCREASED
3 = DISTINCTLY INCREASED
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: mean from 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: corneal opacity was observed in 2/6 animals at day 8 only
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: mean from 24, 48, and 72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: mean from 24, 48, and 72 h
- Score:
- 1.1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: conjunctival redness was observed in 4/6 animals at the end of the observation period
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: mean from 24, 48, and 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
Any other information on results incl. tables
Table: Irritation scores in rabbit eyes
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
op |
ar |
red |
ch |
di |
||||
24 h |
1 |
0 |
0 |
1 |
2 |
1 |
2 |
S |
2 |
0 |
0 |
0 |
1 |
1 |
1 |
||
3 |
0 |
0 |
1 |
2 |
1 |
2 |
||
4 |
0 |
0 |
0 |
1 |
0 |
1 |
||
5 |
0 |
0 |
0 |
1 |
0 |
1 |
||
6 |
0 |
0 |
0 |
1 |
0 |
2 |
S |
|
48 h |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
S |
2 |
0 |
0 |
0 |
1 |
0 |
1 |
||
3 |
0 |
0 |
0 |
1 |
0 |
1 |
||
4 |
0 |
0 |
0 |
1 |
0 |
1 |
||
5 |
0 |
0 |
0 |
1 |
0 |
1 |
||
6 |
0 |
0 |
0 |
1 |
0 |
1 |
S |
|
72 h |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
S |
2 |
0 |
0 |
0 |
1 |
0 |
1 |
||
3 |
0 |
0 |
0 |
1 |
0 |
1 |
||
4 |
0 |
0 |
0 |
1 |
0 |
1 |
||
5 |
0 |
0 |
0 |
1 |
0 |
1 |
||
6 |
0 |
0 |
0 |
1 |
0 |
1 |
S |
|
8 d |
1 |
1 |
1 |
0 |
1 |
0 |
0 |
S |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
||
4 |
1 |
1 |
0 |
1 |
0 |
0 |
||
5 |
0 |
0 |
0 |
1 |
0 |
0 |
||
6 |
0 |
0 |
0 |
1 |
0 |
0 |
S |
|
Mean 24 -72 h |
1 |
0 |
0 |
0.33 |
1 |
0.33 |
1.33 |
|
2 |
0 |
0 |
0 |
1 |
0.33 |
1 |
||
3 |
0 |
0 |
0.33 |
1 |
0.33 |
1.33 |
||
4 |
0 |
0 |
0 |
1 |
0 |
1 |
||
5 |
0 |
0 |
0 |
1 |
0 |
1 |
||
6 |
0 |
0 |
0 |
1 |
0 |
1.33 |
||
Mean 24 -72 h |
1 -6 |
0 |
0 |
0.1 |
1.1 |
0.2 |
1.2 |
|
Symbols:
h = hour
S = scars
op: opacity
ar: area
red: reddening
ch: chemosis
di: discharge
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
