Palmitoyl chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

partly limited documentation; 50 μl instead of 100 μl test substance instilled

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

application volume

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The saline-treated adjacent eye served as a control.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Palmitoyl chloride

EC Number:

203-996-7

EC Name:

Palmitoyl chloride

Cas Number:

112-67-4

Molecular formula:

C16H31ClO

IUPAC Name:

hexadecanoyl chloride

Details on test material:

- Name of test material (as cited in study report): Palmitinsaeurechlorid (=Palmitoyl chloride)
- Analytical purity: 98% (analytical report: ZAX96L00731, Jan. 1997)
- Lot/batch No.: Vers. 98
- Lot/batch No.: Vers. 62/V
- Storage condition of test material: room temperature, sensitive to moisture

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2.06 - 2.23 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one drop of saline into the other eye

Amount / concentration applied:

50 µl

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: see table for further details

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: see table for further details

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 5 d

Remarks on result:

other: see table for further details

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: see table for further details

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: see table for further details

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: see table for further details

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 d

Remarks on result:

other: see table for further details

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: see table for further details

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

Results 14

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

Results 16

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Comment
1	1 h	0	0	2	1
2	1 h	0	0	2	1
1	3 h	0	0	2	1	blood
2	3 h	0	0	2	1	blood
1	24 h	1	0	2	0
2	24 h	1	0	1	1
1	48 h	0	0	1	0
2	48 h	0	0	1	0
1	5 d	0	0	0	0	slight corneal opacity only after fluorescein staining, comparable to the control eye
2	5 d	0	0	0	0	slight corneal opacity only after fluorescein staining, comparable to the control eye
1	8 d	0	0	0	0
2	8 d	0	0	0	0
mean	24 - 48 h	0.50	0.00	1.25	0.25