Palmitoyl chloride

Endpoint summary

Description of key information

Palmitoyl chloride is irritating to the skin, but non-irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h and the other side was treated for 1, 5 or 15 min under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened with test substance.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 3.25 and 3.54 kg

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 1 ml

Duration of treatment / exposure:

Experiment 1: 20 h
Experiment 2: 1, 5, or 15 minutes

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37°C; presumably 1 ml)

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol conc. and 50% (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: Necrosis observed in both animals; see table for further details

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: see table for further details

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: see table for further datails

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: see table for further datails

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

3.67

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: see table for further details

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 d

Remarks on result:

other: see table for further details

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: see table for further details

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: see table for further details

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Descriptive scores of the raw data have been converted to Draize numerical scores. If necroses were reported, erythema scores were given for the surrounding area.

Exposition:	20 h
Animal	Reading	Erythema	Edema	Comment
1	24 h	3	2	anemic necrosis, overlapping 2 finger´s width
2	24 h	3	1
1	48 h	3	2	anemic necrosis, overlapping 2 finger´s width
2	48 h	3	1	white substance deposits
1	72 h	3	2	anemic necrosis, overlapping 2 finger´s width
2	72 h	3	1	white substance deposits
1	4 d	3	2	anemic necrosis
2	4 d	3	1	white substance deposits
1	7 d	2	0	anemic necrosis, surrounding area with scaling
2	7 d	0	0	smooth necrosis
1	8 d	2	0	anemic necrosis, surrounding area with scaling
2	8 d	0	0	smooth necrosis
mean	24 - 72 h	3.00	1.50
1 2	24 - 72 h 24 - 72 h	3.00 3.00	2.00 1.00
Exposition:	15 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	3	0	largely overlapping
2	24 h	3	0	largely overlapping
1	48 h	4	2	largely overlapping
2	48 h	4	2	largely overlapping
1	72 h	4	2	largely overlapping
2	72 h	3	3	largely overlapping
1	4 d	3	2	largely overlapping
2	4 d	3	2	largely overlapping
1	7 d	2	0	rough scaling
2	7 d	0	0	rough scaling
1	8 d	2	0	rough scaling
2	8 d	0	0	rough scaling
mean	24 - 72 h	3.50	1.50
1	24 - 72 h	3.67	1.33
2	24 - 72 h	3.33	1.67

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

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

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

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

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

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

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

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

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

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

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

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

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

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Remarks on result:

not measured/tested

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h and the other side was treated for 1, 5 or 15 min under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened with test substance. While there was a marked irritation after 15 minutes exposure "slight" necrosis (suprafacial) were observed after 20-hour occlusive conditions in both animals. Expert judgement suggests that the compound would not be caustic after a much shorter exposure time (4 hours ) and less stringent conditions (semiocclusive patch) (BASF, 1970).

Eye irritation:

Another internal standard method (BASF test) was used to test eye irritation in rabbits The study is comparable to OECD Guideline 405 with acceptable restrictions however application volume is reduced. Corneal opacity, conjunctivae redness and chemosis were slight and reversible at least after 5 d (BASF, 1970).

Justification for classification or non-classification

Based on the available data on skin irritation the substance is classified as skin irrit. cat. 2 (H315) according to criteria of Regulation EC/1272/2008 (CLP).