Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Remarks:
The test substance (Citronellal; CAS 106-23-0) represents the racemate of the registered substance (R)-3,7-dimethyloct-6-enal (CAS 2385-77-5).
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:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
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:
other: Federal Register 38, No. 187, § 1500.42, p. 27029 from 27.09.73
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Citronellal; CAS 106-23-0; substance number 78/742


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