Quaternary ammonium compounds, C12-14-alkyl[(ethylphenyl)methyl]dimethyl, chlorides

Endpoint summary

Description of key information

Based on the results of the in vivo skin corrosion read across study, the test substance, C12-14 ADEBAC, is considered to be corrosive to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

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:

other: Basic data given, followed methods comparable to guideline EPA OPPTS 870.2500

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)

Remarks:

Intact and abraded skin site

Basis:

mean

Time point:

24/48/72 h

Score:

6.29

Max. score:

8

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Irritation parameter:

erythema score

Remarks:

Intact skin site

Basis:

mean

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Irritation parameter:

erythema score

Remarks:

Abraded skin site

Basis:

mean

Time point:

24/48/72 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Irritation parameter:

edema score

Remarks:

Intact skin site

Basis:

mean

Time point:

24/48/72 h

Score:

2.66

Max. score:

3

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Irritation parameter:

edema score

Remarks:

Abraded skin site

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Irritant / corrosive response data:

- Severe erythema and edema were observed in animals with abraded and intact skin.

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 1 (corrosive) based on CLP criteria

Conclusions:

Based on the results of the read across substance study, the test substance is 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 (active: >93%), according to US EPA OPPTS 870.2500. The experiment was performed in rabbits. The undiluted read across 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 read across 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, the read across substance was considered to be corrosive to rabbit skin (Wallace, 1975). Based on the results of the read across study, similar skin corrosion potential can be expected for the test substance, C12-14 ADEBAC.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

Study 1: A study was conducted to determine the skin irritation / corrosion potential of the read across substance, C12-16 ADBAC (active: >93%), according to US EPA OPPTS 870.2500. The experiment was performed in rabbits. The undiluted read across 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 read across 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, the read across substance was considered to be corrosive to rabbit skin (Wallace, 1975). Based on the results of the read across study, similar skin corrosion potential can be expected for the test substance, C12-14 ADEBAC.

Study 2: A study was conducted to determine the dermal irritation potential of the read across substance, C12-18 ADEBAC (active: 25%), according to the modified Draize test. 0.5 mL read across substance (25%) was applied to abraded and non-abraded skin of 6 rabbits, under occlusive conditions for 24 h. The sites were individually examined and scored separately for erythema and edema at 24 and 72 h after removing wrapping and read across substance. The mean scores for 24 and 72 h gradings were averaged to determine final irritation indices. Severe erythema and edema were observed in animals with abraded and non-abraded skin and the primary irritation index was calculated to be 8. Under study conditions, 25% read across substance was concluded to be a primary dermal irritant and corrosive (Palankar, 1976). Based on the results of the read across study, neat test substance, C12 -14 ADEBAC, can be considered to be corrosive to skin.

Eye:

Eye irritation study does not need to be conducted because the test substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1).

Justification for classification or non-classification

Skin

Based on the results of the read across studies, the test substance, C12-14 ADEBAC, is concluded to warrant ‘Skin Corr. 1B; H314 - causes severe skin burns and eye damage’ classification (similar to the read across substance), according to EU CLP criteria (Regulation 1272/2008/EC).

Eye

Based on the results of the read acrossin vivoskin irritation studies, the test substance, C12-14 ADEBAC, warrants ‘Eye damage 1; H318- causes serious eye damage’ classification, according to EU CLP criteria (Regulation 1272/2008/EC). Labelling for this endpoint is covered by the above classifications for skin effects.​