10-Undecenoic acid, monoester with 1,2,3-propanetriol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 - 14 May 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Limited data on animal husbandry, six animals were used, no anasthetics were used, the test substance purity was not specified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Oct 2012

Deviations:

yes

Remarks:

limited data on animal husbandry, six animals were used, no anasthetics were used, the test substance purity was not specified.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Official method of the French Republic published in 'Journal Officiel' 21 Feb 1982 and 24 Oct 1984

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): undecylenate de glycerol
- Physical state: white congealed paste
- Analytical purity: no data
- Lot/batch No.: 1007C
- Storage condition of test material: at room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: COB.LABO.LAP, Yffiniac, France
- Weight at study initiation: approximately 2.1 kg
- Housing: animals were housed individually
- Acclimation period: 3 weeks

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h, and day 4 and 7 (mean values only given for day 7)

Number of animals or in vitro replicates:

6 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 4 d

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 4 d

Results 8

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 d

Results 9

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

One hour after instillation of the test substance, 6/6 rabbits had obvious swelling (chemosis score 2) and 1/6 rabbits had some conjunctivae (score 1). At the 24-hour reading time point, chemosis (score 1-2) was observed in 6/6 animals. The chemosis gradually reduced in severity, persisting in 4/6 at the 48-hour reading time point, in 3/6 at the 72-hour reading time point, and in 1/6 until 4 days after instillation. No conjunctivae was observed in any animal from 24 hours after instillation. No irritation effects were seen on the iris and cornea in any animal at any reading time point. Only mean values were given for Day 7, and it is therefore not possible to determine if the irritation effects had cleared by Day 7.

Any other information on results incl. tables

Table 1. Eye irritation scores

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	0	2	0	0
	24 h	0	2	0	0
	48 h	0	0	0	0
	72 h 4 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.67	0.0	0.0
2	1 h	0	2	0	0
	24 h	0	2	0	0
	48 h	0	2	0	0
	72 h 4 d	0 0	1 0	0 0	0 0
	Average*	0.0	1.67	0.0	0.0
3	1 h	0	2	0	0
	24 h	0	2	0	0
	48 h	0	1	0	0
	72 h 4 d	0 0	0 0	0 0	0 0
	Average*	0.0	1.0	0.0	0.0
4	1 h	0	2	0	0
	24 h	0	1	0	0
	48 h	0	1	0	0
	72 h 4 d	0 0	1 1	0 0	0 0
	Average*	0.0	1.0	0.0	0.0
5	1 h	1	2	0	0
	24 h	0	1	0	0
	48 h	0	1	0	0
	72 h 4 d	0 0	1 0	0 0	0 0
	Average*	0.0	1.0	0.0	0.0
6	1 h	0	2	0	0
	24 h	0	2	0	0
	48 h	0	0	0	0
	72 h 4 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.67	0.0	0.0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified