4,8-dimethyl-4,9-decadienal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 May 1984 - 5 May 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability 2 is assigned because the study was conducted according to an acceptable method comparable to OECD TG 405 and in compliance with GLP, but with minor deviations that do not influence the test results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(number of animals used, lack of extended observation period, slight differences in grading system which do not influence the relevance of the results)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Federal Register 1973, Volume 38, No. 187, 1500.42

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,8-dimethyl-4,9-decadienal

EC Number:

275-174-6

EC Name:

4,8-dimethyl-4,9-decadienal

Cas Number:

71077-31-1

Molecular formula:

C12H20O

IUPAC Name:

4,8-dimethyl-4,9-decadienal

Test material form:

other: liquid

Details on test material:

- Storage condition of test material: in a brown glass screw-top bottle at ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leics.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.21-2.53 kg
- Housing: individually, in suspended metal cages
- Diet (e.g. ad libitum): standard laboratory diet (Rabbit Diet, A.W. Tindall Limited), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: minimum five days prior to start of study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 61-65 %
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eye of test animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
Assessment of damage/irritation was made at 24, 48 and 72 hours following treatment according to the numerical evaluation according to Draize J.H. 1959, Assoc. of Food and Drug Officials of the USA, Austin, Texas, "The appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics"). Readings were performed at 24, 48 and 72 48 hours after instillation.

TOOL USED TO ASSESS SCORE:
Examination was done by the use of a standard opthalmoscope (Keeler). Observation of corneal opacity was carried out under ultra-violet illumination (Mineralight UVSL-58) preceded by the instillation into the eye or fluorescein B.P.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal: #1, #2, #3, #4 and #5

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #6

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0.33

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4 and #5

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

2

Results 4

Irritation parameter:

iris score

Basis:

animal #6

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #4

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1 and #6

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1.67

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 7

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #2, #3 and #5

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #2, #3 and #4

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Irritant / corrosive response data:

The test material produced minimal or slight ocular irritation in 6 out of 6 animals.
- Cornea: diffuse opacity was observed in one rabbit, dulling of the normal lustre of the cornea was seen in two other rabbits (24 hours reading). Dulling was still apparent in one rabbit after 48 hours and 72 hours reading.
- Iris: iritis was observed in one rabbit at 24 and 48 hours reading only.
- Conjunctivae/chemosis: diffuse, crimson-red colouration including slight/distinct swelling of eyelids was observed in 3 rabbits at 24 hours reading. Mild reactions were seen in other 3 animals. At 48 hours, mild inflammation with or without distinct swelling and partial eversion of the eyelid was observed in all animals. This persisted in 4 animals up until the 72 hours reading.
Despite slight irritation at the end of the 72h observation period it is anticipated that the irritation will be resolved within 14 days because of the slight nature of the effect.

Any other information on results incl. tables

Individual scores and individual general totals for ocular irritation:

Rabbit number	1 (619)			2 (413)			3 (419)			4 (427)			5 (429)			6 (431)
Hours after treatment	24	48	72	24	48	72	24	48	72	24	48	72	24	48	72	24	48	72
Cornea
E = Degree of opacity	0	0	0	D	0	0	D	0	0	0	0	0	0	0	0	1*	D	D
F = Area of opacity	0	0	0	4	0	0	4	0	0	0	0	0	0	0	0	1	1	1
Score (ExF)x5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	0	0
Iris
D	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1*	1*	0
Score (Dx5)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5	0
Conjunctivea
A = Redness	2*	1	1	2*	1	0	1	1	1	1	1	0	1	1	1	2*	1	1
B = Chemosis	2*	1	1	1	1	0	1	1	0	1	1	0	0	0	0	2*	2*	2*
C = Discharge	1	0	0	1	0	0	1	0	0	1	0	0	0	0	0	3	1	0
Score (A+B+C)x2	10	4	4	8	4	0	6	4	2	6	4	0	2	2	2	14	8	6
Individual general totals	10	4	4	8	4	0	6	4	2	6	4	0	2	2	2	24	13	6
	GT1	GT2	GT3	GT1	GT2	GT3	GT1	GT2	GT3	GT1	GT2	GT3	GT1	GT2	GT3	GT1	GT2	GT3

* = Positive reaction

D – Dulling of the cornea

Based on the classification systems as included in the study report, the classification of the substance is as follows:

- Classification according to Federal Register 1973:

3/6 rabbits showed positive ocular reactions and the test material therefore gave an INCONCLUSIVE result according to the Federal Register.

 

- E.T.A.D. Classification (Scoring system based on Draize 1959):

The test material produced a Group Mean 3 -Day Score of 5.6 and was therefore classified as NON-IRRITANT to the eye according to ETAD.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an eye irritation study with rabbits, performed according to a method similar to OECD TG 405, the corneal opacity and/or iritis score were not ≥1 and/or the conjunctival redness and/or oedema (chemosis) score were not ≥2. Based on these results, the substance does not need to be regarded as an eye irritant.

Executive summary:

The potential of Floral Super to cause eye irritation was determined in a test according to a method similar to OECD guideline 405. Six New Zealand White female rabbits were exposed to 0.1 ml of the undiluted test article in one of the eyes. The other eye served as a control. The eyes were examined and the changes graded according to a numerical scale 24, 48 and 72 hours after dosing.

The test material produced minimal or slight ocular irritation in 6 out of 6 rabbits. The corneal opacity and/or iritis score were not ≥1 and/or the conjunctival redness and/or oedema (chemosis) score were not ≥2. Reversibility of the effect within 14 days can be anticipated. Based on these results, the substance does not need to be regarded as an eye irritant.