Undec-10-enoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-03-23 till 1999-04-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Undec-10-enoic acid

EC Number:

203-965-8

EC Name:

Undec-10-enoic acid

Cas Number:

112-38-9

Molecular formula:

C11H20O2

IUPAC Name:

undec-10-enoic acid

Details on test material:

- Physical state: Colorless solid
- Analytical purity: 99.5%
- Storage condition of test material: in dark at RT
- batch 9807016 filling 41/99

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

all males

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

a single administration

Observation period (in vivo):

1h, 24h, 48h, 72 h

Number of animals or in vitro replicates:

3

Details on study design:

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 11

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other:

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: day 9

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 13 days

Remarks:

day 13

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 5

Remarks:

within day 5

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 5

Remarks:

within day 5

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other:

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: day 10

Remarks:

day 10

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8, days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 9

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: Day 15

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea (opacity)	Iris	Conjunctivae (Redness)	Chemosis	Conjunctivae (Discharge)
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4	Max. score: 4
60 min	0/0/0	0/0/0	0/2/2	3/3/3	2/2/2
24 h	2/1/1	1/0/1	2/2/2	3/2/3	S/2//2
48 h	2/1/1	1/0/1	2/2/2	3/2/3	S/1/1
72 h	1/1/1	1/1/1	2/1/1	3/2/2	0/0/1
Average 24h, 48h, 72h	1.7/1/1	1/0.3/1	2/1.7/1.7	3/2/2.7	0.7/1/1.3
Reversibility*)	c/c/c	c/c/c	c/c/c	c/c/c	c/c/c
Average time (days) for reversion	6.7	4.7	7.3	9.7	3.7

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

s= whitish purulent discharge

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

According to CLP (regulation EC, No 1272-2008), the test substance Acide Undecylenique is to be classified as "Eye IrritantCategory 2 (irritating to eyes)"

Executive summary:

The potential of the test substance ACIDE UNDECYLENIQUE to induce ocular irritation was evaluated in rabbits according to OECD guideline No. 405/ and EU directive 92/69/EEC B.5. 0.1 g Acide Undecylenique was placed in the conjunctival sac of the left eye of three male New Zealand White rabbits. Animals were observed for 15 days. Eye irritation was scored and mean values for chemosis, redness of conjunktiva, iris lesions and corneal opacity were calculated. Very slight to moderate conjunctival reactions were observed in all animals from day 1; these reactions persisted up to day 14 at the latest. A slight iritis was noted in two animals at day 2, it persisted up to day 4 or 10, respectively. A very slight or slight corneal opacity was recorded in all animals on day 2; it persisted up to day 4 (two animals) or 12. Under the experimental conditions, the test substance ACIDE UNDECYLENIQUE is irritant when administered by ocular route to rabbits.