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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study
Justification for type of information:
Read-across data is presented from quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808-53-2, EC Number 276-038-9. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides
EC Number:
276-038-9
EC Name:
Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides
Cas Number:
71808-53-2
IUPAC Name:
Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides
Test material form:
liquid
Specific details on test material used for the study:
Name: C12-18-alkylbis(hydroxyethyl)methyl, chloride (77% in isopropyl alcohol)
CAS No.: 71808-53-2 (old CAS No. 70750-47-9)
Chemical Name: C12-18-alkylbis(hydroxyethyl)methyl, chloride
Batch No.: S001314
Physical state at RT: liquid
Colour: amber
Active Components: 77.3%
Storage: at room temperature
Expiry Date: 28.04.2018

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Semi barrier in an air-conditioned room
- Temperature: 18 +/- 3 °C (recommendations of TVT, GV-SOLAS)
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 0700), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days) under laboratory conditions

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
As the test item was suspected to be corrosive, three patches were applied to one animal. The exposure periods were 3 min, 1 hour and 4 hours.
At the end of the exposure period, the residual test item was removed with tap water.
Observation period:
14 days after the patch removal
Number of animals:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Remarks on result:
other: 3 min exposure - 24h to 48h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
1
Remarks on result:
other: 3 min exposure - 24h to 48h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Remarks on result:
other: 1h exposure - 24h to 72h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Remarks on result:
other: 1h exposure - 24h to 72h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Remarks on result:
other: 4h exposure - 24h to 72h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Remarks on result:
other: 4h exposure - 24h to 72h
Irritant / corrosive response data:
Initial test in animal no. 1: The examination of the test site immediately after the patch removal revealed erythema grade 1 and oedema grade 1 for the 3 min exposure, erythema grade 1 and oedema grade 2 for the 1 hour exposure and erythema grade 2 and oedema grade 3 for the 4 hour exposure.
The subsequent clinical observations showed irritant effects for the 3 min exposure and corrosive effects for the 1 hour and 4 hours exposure, which were not reversible within the observation period of 14 days.
Irritant effects were observed on the intact skin of one female rabbit (strain NZW) after a contact time of 3 min (Tables), corrosive effects were observed on the intact skin of one female rabbit after a contact time of 1 hour and 4 hours. These signs of irritation / corrosion were not reversible within the observation period of 14 days.

Any other information on results incl. tables

Dermal Irritation Evaluation

Exposure Time

Application
Site

Irritation (hours after patch removal)

1 hour

24 hours

48 hours

72 hours

T

C

T

C

T

C

T

C

3 min

Erythema

1

0

2

0

2

0

2

0

Oedema

1

0

1

0

1

0

1

0

1 hour

Erythema

1

0

3

0

3

0

3

0

Oedema

2

0

2

0

2

0

2

0

4 hours

Erythema

3

0

4

0

4

0

4

0

Oedema

3

0

2

0

2

0

2

0

Exposure Time

Application
Site

Irritation (days after patch removal)

4 days

5 days

6 days

7 days

T

C

T

C

T

C

T

C

3 min

Erythema

2

0

2

0

2

0

1

0

Oedema

1

0

1

0

0

0

0

0

1 hour

Erythema

3

0

3

0

3

0

2

0

Oedema

2

0

2

0

0

0

0

0

4 hours

Erythema

4

0

4

0

4

0

4

0

Oedema

2

0

2

0

0

0

0

0

Exposure Time

Application
Site

Irritation (days after patch removal)

8 days

9 days

10 days

11 days

T

C

T

C

T

C

T

C

3 min

Erythema

1

0

1

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

1 hour

Erythema

2

0

2

0

1

0

1

0

Oedema

0

0

0

0

0

0

0

0

4 hours

Erythema

4

0

4

0

4

0

3

0

Oedema

0

0

0

0

0

0

0

0

Exposure Time

Application
Site

Irritation (days after patch removal)

12 days

13 days

14 days

 

T

C

T

C

T

C

 

3 min

Erythema

1

0

1

0

0

0

 

Oedema

0

0

0

0

0

0

 

1 hour

Erythema

2

0

2

0

1

0

 

Oedema

0

0

0

0

0

0

 

4 hours

Erythema

4

0

4

0

4

0

 

Oedema

0

0

0

0

0

0

 

Other findings:

Individual Systemic and Local Findings – 3 min exposure

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

nsf

-

48 hours

nsf

nsf

-

72 hours

nsf

nsf

-

4 days

nsf

eschar, superficial cleft

-

5 days

nsf

eschar, superficial cleft

-

6 days

nsf

eschar, superficial cleft

-

7 days

nsf

eschar, desquamation

-

8 days

nsf

eschar, desquamation

-

9 days

nsf

eschar, desquamation

-

10 days

nsf

eschar, desquamation

-

11 days

nsf

eschar, desquamation

-

12 days

nsf

eschar, desquamation

-

13 days

nsf

dequamation

-

14 days

nsf

dequamation

-

Individual Systemic and Local Findings – 1 hour exposure

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

eschar

-

48 hours

nsf

eschar

-

72 hours

nsf

eschar

-

4 days

nsf

eschar, cleft

-

5 days

nsf

eschar, cleft

-

6 days

nsf

eschar, cleft

-

7 days

nsf

eschar, desquamation

-

8 days

nsf

eschar, desquamation

-

9 days

nsf

eschar, desquamation

-

10 days

nsf

eschar, desquamation

-

11 days

nsf

eschar, desquamation

-

12 days

nsf

eschar, desquamation

-

13 days

nsf

eschar, desquamation

-

14 days

nsf

eschar, desquamation

-

Individual Systemic and Local Findings – 4 hours exposure

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

eschar

-

48 hours

nsf

eschar

-

72 hours

nsf

eschar

-

4 days

nsf

eschar

-

5 days

nsf

eschar

-

6 days

nsf

eschar

-

7 days

nsf

eschar

-

8 days

nsf

eschar

-

9 days

nsf

eschar

-

10 days

nsf

eschar

-

11 days

nsf

eschar

-

12 days

nsf

eschar

-

13 days

nsf

eschar

-

14 days

nsf

eschar

-

Body Weight Develompent:

 

Animal No. 1

Start of Study
(weight in kg)

2.5

72 Hours after Application (weight in kg)

2.4

End of Study
(weight in kg)

2.7

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the conditions of the present study, the single dermal application of the test item C12-18-alkylbis(hydroxyethyl)methyl, chloride (77% in isopropyl alcohol) to one rabbit at a dose of 0.5 g for 3 min exposure showed irritant effects, for 1 hour and 4 hours exposure showed corrosive effects which were not fully reversible within the observation period.
Executive summary:

The skin irritation / corrosion potential of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study conducted according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) / EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) / EPA OPPTS 870.2500 (Acute Dermal Irritation).

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Under the conditions of the present study, the single dermal application of the test item C12-18-alkylbis(hydroxyethyl)methyl, chloride (77% in isopropyl alcohol) to one rabbit at a dose of 0.5 g for 3 min exposure showed irritant effects, for 1 hour and 4 hours exposure showed corrosive effects which were not fully reversible within the observation period.

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