Propionic anhydride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Principles of method if other than guideline:

Before OECD Guideline 404 was established, skin irritation was tested using an internal BASF method. The undiluted substance was applied to the clipped back (2.5 X 2.5 cm) of 2-4 animals for short periods of time (1, 5 and 15 mins). At the end of treatment, the application site was washed first with lutrol and then with 50% aqueous lutrol solution. The animals were observed for up to 53 days and skin changes were assessed and scored.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propionic acid

EC Number:

201-176-3

EC Name:

Propionic acid

Cas Number:

79-09-4

Molecular formula:

C3H6O2

IUPAC Name:

propanoic acid

Details on test material:

Source: Nonylfabrik (Hochdruck Abteilung)
Analytical purity: > 99%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.25-2.85 kg

ENVIRONMENTAL CONDITIONS
- no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

1, 5, 15 min

Observation period:

53 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (undiluted lutrol and 50% lutrol in water)
- Time after start of exposure: after 1, 5 and 15 min

SCORING SYSTEM: The test was initially scored using a BASF numerical skin grading system. Later these scores were converted to the scoring system by Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(after 1 min of exposure)

Basis:

mean

Remarks:

(4 animal)

Time point:

other: 24 and 72 hour

Score:

1.25

Max. score:

4

Reversibility:

fully reversible within: 30 days

Remarks on result:

other: crust formation (after 8 days) and scaling (till 30 days) were apparent

Results 2

Irritation parameter:

erythema score

Remarks:

(after 5 mins of exposure)

Basis:

mean

Remarks:

(of 4 animals)

Time point:

other: 24 and 72 hours

Score:

1.9

Max. score:

4

Reversibility:

fully reversible within: 23 days

Remarks on result:

other: Brown and anaemic skin colouration was evident shortly after removal of patch (lasted up to 8 days after application). Necrosis and crusty skin from 24 h post termination of exposure was apparent. Scar tissue at end after 53 days

Results 3

Irritation parameter:

erythema score

Remarks:

(exposure duration of 15 min)

Basis:

mean

Remarks:

(2 animals)

Time point:

other: 24 and 72 hours

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 15 days

Remarks on result:

other: Necrosis was evident as from 24 h post termination of exposure. Crust formation induced after 72. At termination (53 days) bloody and deep penetrative scars were apparent.

Results 4

Irritation parameter:

edema score

Remarks:

(after 1 min of exposure)

Basis:

mean

Remarks:

(of 4 animals)

Time point:

other: 24 and 72 hours

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

edema score

Remarks:

(after 5 min of exposure)

Basis:

mean

Remarks:

(of 4 animals)

Time point:

other: 24 and 72 hour

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

edema score

Remarks:

(after 15 min of exposure)

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24 and 72 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 15 days

Irritant / corrosive response data:

- Necrosis after exposure periods of 5 and 15 minutes of exposure
- Crustaceous tissue was present after 1 minutes of exposure

Any other information on results incl. tables

Table 1: Results after 15 min duration

 

Animal	Animal	Erythema	Edema	Further findings
Immediately after removal of patch   (15 min)	1	3	3	Anemic appearance, erythema at edges
	2	3	3	Anaemic appearance, erythema at edges and oedema
24h	1	3	0	Anemic appearance, erythema at edges
	2	3	3	Brown discolouration, anaemic appearance, erythema at elevated edges
72h	1	3	0	Anaemic application site with reddened edges and oedema, beginning necrosis
	2	3	3	Penetrative crust, reddened edges
8d	1	3	0	Brown and partly anaemic necrosis with reddened edges
	2	0	0	necrosis
15d	1	0	0	Hardened penetrative crust
	2	0	0	Bloody penetrative scar
53 d      (8 weeks)	1	0	0	Scar
	2	0	0	Bloody penetrative scar
Mean scores (24-72h)	1	3	3
	2	3	0

 

Table 2: Results after 5 min exposure duration

Readings	Animal	Erythema	Edema	Further findings
At removal (after 5 min)	1	3	3	Anaemic in the middle with reddened and oedematous edges
	2	3	3
	3	3	3
	4	3	3
24h	1	3	3	Anaemic in the middle with reddened and oedematous edges
	2	3	0	Brown discolouration in the middle, partly anaemic with reddened elevated edges
	3	3	0	Anaemic in the middle, partly brown necrotic tissue with reddened edges
	4	0	0	Anaemic in the middle, partly brown discolouration
72h	1	3	0	Anaemic leather-like crust
	2	3	0	Anaemic crust with reddened edges, partly brown
	3	0	0	Deep penetrative crust
	4	0	0	Anaemic in the middle, partly brown discolouration
8d	1	3	0	Anaemic necrosis with reddened edges
	2	3	0	Deep penetrative crust with reddened elevated edges
	3	0	0	-
	4	0	0	Anaemic crust with reddened edges
15d	1	0	0	Hard deep and penetrative crust
	2	0	0	Crust partly detached
	3	0	0	-
	4	0	0	-
23 d	1	0	0	Hard deep and penetrative crust
	2	0	0	Detaching crust/bloody scar
	3	0	0	Deep penetrative and bloody crustaceous scar
	4	0	0	Thick yellow crust, partly detached
8 weeks (53 d)	1	0	0	Scaring tissue
	2	0	0	Bloody scar/extensive scar
	3	0	0	Scar with increased hair growth
	4	0	0	Deep penetrative and bloody crustaceous scar
MW (24-72h)	1	3	1.5
	2	3	0
	3	1.5	0
	4	0	0

 

Table 3: Results after 1 min exposure duration

Readings	Animal	Erythema	Edema	Further findings
At removal (after 1 min)	1	2	0	-
	2	2	0	bleeding
	3	2	3	-
	4	2	3
24h	1	1	0
	2	1	0
	3	2	2
	4	2	0
72h	1	0	0
	2	0	0	Symptom free
	3	2	2	-
	4	2	0
8d	1	0	0	scaling
	2	0	0	-
	3	2	0	Scaling, crusty edges
	4	0	0	Symptom free
15d	1	0	0
	2	0	0
	3	0	0
	4	0	0
30 d	1	0	0	Increased hair growth
	2	0	0	-
	3	0	0	scaling
	4	0	0	scaling
MW (24-72h)	1	0.5	0
	2	0.5	0
	3	2	2
	4	2	0

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information