Citral

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 Oct - 13 Oct 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study similar to guideline study with the acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(reduced test volume of 50 µL; observation period 8 days; no reading at 72 hrs; 2 test animals used)

Principles of method if other than guideline:

Internal method (BASF test): 2 test animals, applied volume 50 µL , scoring at 1, 3, 24, and 48 hrs, and 5, 7, and 8 days after instillation; scores converted to grades according to Draize

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Citral

EC Number:

226-394-6

EC Name:

Citral

Cas Number:

5392-40-5

Molecular formula:

C10H16O

IUPAC Name:

3,7-dimethylocta-2,6-dienal

Constituent 2

Reference substance name:

(Z)-3,7-dimethylocta-2,6-dienal

EC Number:

203-379-2

EC Name:

(Z)-3,7-dimethylocta-2,6-dienal

Cas Number:

106-26-3

Molecular formula:

C10H16O

IUPAC Name:

(2Z)-3,7-dimethylocta-2,6-dienal

Details on test material:

3,7-Dimethyloctadien-2,6-al-1
Purity: >= 95 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.19 and 2.01 kg
- Sex: females

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the respective animal

Duration of treatment / exposure:

not applicable; eyes were not washed out after 24 h as recommended in the OECD Guideline 405

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATIONS
- after 1 and 3 hours, 1, 2, 5, 7 and 8 days

SCORING SYSTEM:
- The original BASF grading was converted into the numerical grading according to the OECD Draize system.

TOOL USED TO ASSESS SCORE:
- fluorescein, at the end of the study

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

other: 24 and 48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 and 48 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 and 48 h

Score:

1.5

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24 and 48 h

Score:

1.25

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

For details see Table:
Both animals showed an opacity of the cornea of grade 1 after 24 and 48 hrs and on day 5. Thereafter this finding was completely reversible.
Findings of the conjunctiva were redness which persisted in both animals throughout the whole observation period (grade 1 with the exception of a grade 2 score in one animal at 24 and 48 hrs). Chemosis was observed after 24 and 48 hrs and after 5 days (grade 1 except for grade 2 in one animal at 24 hrs) and was reversible thereafter. Scar formation on the conjunctiva was observed after 24 hrs in both animals. During the further observation period this finding was present only in one animal on days 2, 5 and 7.
Additionally, secretion was reported from 24 hrs up to 5 days (grade 1).

Any other information on results incl. tables

Table: Scores for changes of the cornea, iris and conjunctiva:

Readings	animal	cornea	iris	conjunctiva
		opacity/area		redness	chemosis	secretion
1 h	1	0/0	0	1	0	0
	2	0/0	0	1	0	0
3 h	1	0/0	0	1	0	0
	2	0/0	0	1	0	0
24 h	1	1/4	0	1*	1	1
	2	1/4	0	2*	2	1
48 h	1	1/4	0	1	1	1
	2	1/4	0	2*	1	1
5 d	1	1/2	0	1	1	1
	2	1/1	0	1*	1	1
7 d	1	0/0	0	1	0	0
	2	0/0	0	1*	0	0
8 d	1	0/0	0	1	0	0
	2	0/0	0	1	0	0
Mean 24 h, 48 h	1	1/4	0	1	1
	2	1/4	0	2	1.5
Mean 24 h, 48 h	1 - 2	1/4	0	1.5	1.25

* scar

Observations after 8 days with fluorescein: no findings

Control eyes: no findings