Benzododecinium chloride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Refer to section 13 of IUCLID for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

yes

Remarks:

1. In the study, abraded and non abraded skin sites were used; however, the guideline recommends unabraded skin. 2. Exposure period was 24 h; however, guideline recommends 4 h exposure period

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

other: The test substance was applied to both abraded and intact skin

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:

24h

Observation period:

24 and 72h

Number of animals:

6

Details on study design:

Test site:
- Area of exposure: Back of animal
- Type of wrap if used: The patches consisted of two layers of light gauze cut in squares (2.5 cm on the side). The patches were secured to the test area by thin bands of adhesive tape and the trunk of each animal was wrapped in clear plastic trunk bands after application of the test substance.
- Type of test site: Two areas (intact and abraded) on the back of each animal placed approximately 10 cm apart

Scoring system:
- Skin reactions were scored for erythema and edema, according to Draize Woodland and Calvery scoring system.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24h and 72h

Score:

6.29

Max. score:

8

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: Intact and abraded skin site

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h and 72h

Score:

3.33

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: Intact skin site

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h and 72h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: Abraded skin site

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h and 72h

Score:

2.66

Max. score:

3

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: Intact skin site

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h and 72h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: Abraded skin site

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24/72 h

Score:

ca. 3.5 - ca. 4

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 3.5 for intact and 4 for abraded skin)

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 / 72 h

Score:

ca. 3 - ca. 3.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 3 for intact and 3.5 for abraded skin)

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 / 72 h

Score:

ca. 3.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 3.5 for intact and 3.5 for abraded skin)

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24 / 72 h

Score:

ca. 3.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 3.5 for intact and 3.5 for abraded skin)

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 24 / 72 h

Score:

ca. 3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 3 for intact and 3 for abraded skin)

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 24 / 72 h

Score:

ca. 3.5 - ca. 4

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 4 for intact and 3.5 for abraded skin)

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 / 72 h

Score:

ca. 2.5 - ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 2.5 for intact and 3 for abraded skin)

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 / 72 h

Score:

ca. 2.5 - ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 2.5 for intact and 3 for abraded skin)

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24/72 h

Score:

ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 3 for intact and 3 for abraded skin)

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24/72 h

Score:

ca. 2.5 - ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 2.5 for intact and 3 for abraded skin)

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24/72 h

Score:

ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 3 for intact and 3 for abraded skin)

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24/72 h

Score:

ca. 2.5 - ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Remarks:

(mean erythema score was: 2.5 for intact and 3 for abraded skin)

Irritation parameter:

erythema score

Time point:

24/48/72 h

Remarks on result:

other: see below table for details on results

Irritation parameter:

edema score

Time point:

24/48/72 h

Remarks on result:

other: see below table for details on results

Irritant / corrosive response data:

- Severe erythema and edema were observed in animals with abraded and intact skin. See below table for individual animal scores at each time point.

Table 1. Individual animal data on the skin irritation response

Rabbit no.	Reaction	24 h		72 h
		Intact	Abraded	Intact	Abraded
1	Erythema	4	4	3	4
	Edema	2	3	3	3
2	Erythema	3	4	3	3
	Edema	2	3	3	3
3	Erythema	4	4	3	3
	Edema	3	3	3	3
4	Erythema	4	4	3	3
	Edema	2	3	3	3
5	Erythema	3	3	3	3
	Edema	3	3	3	3
6	Erythema	4	4	4	3
	Edema	2	3	3	3

 

Interpretation of results:

other: Category 1B (corrosive) based on CLP criteria

Conclusions:

Based on the results of the read across study, the test substance, C12 ADBAC, can be considered to be corrosive to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the read across substance, C12 -16 ADBAC (50 -80% active), according to US EPA OPPTS 870.2500. The experiment was performed in rabbits. The undiluted test substance was applied on intact and abraded skin sites using occlusive patches for an exposure period of 24 h. The skin was then observed for erythema and edema formation and the scoring was done according to the Draize, Woodland and Calvery scoring system at 24 and 72 h from the onset of exposure. Severe erythema and edema were observed in all the test animals at both the abraded and intact sites. The mean Primary Irritation Index (PII) of the test substance was calculated to be 6.29 and the mean values of erythema and edema were 3.33 (intact skin site), 3.5 (abraded skin site), 2.66 (intact skin site) and 3 (abraded skin site). Under study conditions, C12 -16 ADBAC is considered to be corrosive to rabbit skin (Wallace, 1975). Based on the results of the read across study, the test substance, C12 ADBAC, can be considered to be corrosive to rabbit skin.