Esterification products of alkenylsuccinic anhydride and 2-dialkylaminoethanol

Skin irritation / corrosion

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4th May 1993 to 18th May 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 4421 to 5333 grams
- Housing: Individual suspended mesh bottom cages
- Diet:ad libitum
- Water: tap water ad libitum
- Acclimation period: a minimum of 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 42-76 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6 females

Details on study design:

TEST SITE
- Area of exposure: Back
- Type of wrap if used: Each sample was applied under a 2.5 cm² gauze patch that was overwrapped with a gauze binder and secured with tape. Plastic restraint collars were applied and remained on the animals for the duration of exposure.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure period, the test site was wiped with paper towels moistened with mineral oil (USP).

OBSERVATION TIME POINTS
The rabbits were observed at 1, 24, 48 and 72 hours after partch removal and daily thereafter through day 14 if irritation persisted.

SCORING SYSTEM:
- Method of calculation: Draize
Erythema and Eschar Formation
No erythema – 0
Very slight erythema (barely perceptible, edges of area not well defined) – 1
Slight erythema (pale red in colour) – 2
Moderate to severe erythema (definite red in colour and area well defined) – 3
Severe erythema (beet or crimson red) to slight eschar formation (injuries in depth) – 4
Oedema formation
No Oedema – 0
Very slight oedema (barely perceptible, edges of area not well defined) – 1
Slight oedema (edges of area well defined by definite raising) – 2
Moderate oedema (raised approximately 1 mm) – 3
Severe oedema (raised more than 1 mm and sever oedema extending beyond area of exposure) - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 12 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 12 days

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 11

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 12 days

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test material induced slight to moderate erythema on all rabbits and very slight to slight oedeman in four rabbits. Desquamation was presented on all sites by day 7. All oedema completely subsided by day 9 or earlier. Minor reversible (grade 1) erythema on one site and desquamation on four sites persisted through study termination.

Other effects:

There were no unscheduled deaths during the course of the study.
There were no significant effects on body weight changes during the study (animals were weighed on day 0 and at study termination).

Any other information on results incl. tables

Table 1: Results

 

Animal	Observation	1 hour	24 hours	48 hours	72 hours	4 days	5 days	6 days	7 days	8 days	9 days	10 days	11 days	12 days	13 days	14 days
1	Erythema	2	3	3	3	3	3d	2d	2d	1d	1d	1d	1d	1d	1d	1d
	Oedema	0	1	1	1	2	2	1	1	1	0	0	0	0	0	0
2	Erythema	2	2	2	2	2d	2d	2d	1d	1d	1d	0d	0d	0d	0	-
	Oedema	0	1	0	0	0	0	0	0	0	0	0	0	0	0	-
3	Erythema	2	3	3	3	3	3d	2d	2d	2d	1d	1d	1d	0d	0d	0d
	Oedema	0	1	1	1	1	1	1	0	0	0	0	0	0	0	0
4	Erythema	2	2	2	2	2	2	1	1d	1d	1d	1d	0d	0d	0d	0d
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5	Erythema	2	3	2	3	3d	3d	3d	2d	2d	1d	1d	1d	0d	0d	0d
	Oedema	1	1	1	1	2	2	1	1	0	0	0	0	0	0	0
6	Erythema	2	2	2	2	2	2d	1d	1d	1d	1d	1d	1d	0d	0	-
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	-
d = desquamation - = animal terminated from study, irritation previously subsided.

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material induced slight to moderate erythema on all rabbits. Four sites had very slight to slight oedema. Desquamation was present on all sites by the end of the first week of the study. In general erythema and oedema had completely subsided by day 12 or earlier with the exception of one animal where very slight erythema persisted to day 14. Four animals had desquamation at study termination. The primary irritation index was calculated as 2.8 which equates to the description of moderately irritating, however in accordance with the criteria outlined in Regulation EC 1272/2008 (CLP), the test material is not classified.

Executive summary:

The skin irritation of the test material was investigated in female albino rabbits in accordance with OECD 404, EU Method B.4 and EPA OTS 798.4470. The test material induced slight to moderate erythema on all rabbits. Four sites had very slight to slight oedema. Desquamation was present on all sites by the end of the first week of the study. In general erythema and oedema had completely subsided by day 12 or earlier with the exception of one animal where very slight erythema persisted to day 14. Four animals had desquamation at study termination.  The primary irritation index was calculated as 2.8 which equates to the description of moderately irritating, however in accordance with the criteria outlined in Regulation EC 1272/2008 (CLP), the test material is not classified (the test material induced a positive response in 3/6 animals).