Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 15, 1987 to September 29, 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Didecyldimethylammonium chloride

EC Number:

230-525-2

EC Name:

Didecyldimethylammonium chloride

Cas Number:

7173-51-5

Molecular formula:

C22H48N Cl

IUPAC Name:

N,N-Didecyl-N,N-dimethylammonium chloride

additive 1

Reference substance name:

Propan-2-ol

EC Number:

200-661-7

EC Name:

Propan-2-ol

Cas Number:

67-63-0

Molecular formula:

C3H8O

IUPAC Name:

propan-2-ol

additive 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Details on test material:

- Didecyldimethylammonium chloride (DDAC)
- EC number: 230-525-2

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12-16 wk
- Weight at study initiation: 2.19 - 2.42 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: closely clipping the fur from the dorsal/flank areas using veterinary clippers

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Undiluted

Duration of treatment / exposure:

Upto 60 min

Observation period:

The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Clipped dorsal flanks
- Type of wrap if used: Occlusive patches
- 0.5 mL of test material was applied under occlusive patches on the clipped dorsal flanks of three rabbits and left for 3 min application on one flank and 60 min application on the other flank.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in 3 % (v/v) aqueous acetic acid followed by cotton wool soaked in distilled water.

EVALUATION:
Approximately 1 h following removal of the patches and 24, 48 and 72 h and 7 and 14 d later, the test sites (a total of six) were examined for evidence of primary irritation and scored according to Draize (1959).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(for 1 h exposure)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Eschar, moderate erythema extending beyond site, blanching of skin, scattered punctate formation

Results 2

Irritation parameter:

edema score

Remarks:

(for 1 h exposure)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3.56

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Oedema extending beyond site

Irritant / corrosive response data:

No data

Other effects:

No data

Any other information on results incl. tables

After three minutes exposure:

No adverse skin reaction were noted at any treated skin site 1 h after the removal of the patches. Very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at  all  the  treated  sites  at the  48  and 72 h  observations. Very slight oedema was noted at one treated site at the 24 and 48 h observations and at two treated sites at the 72 h observation. 

After one hour exposure:
A light brown discoloration of the epidermis and slight haemorrhage of the dermal capillaries were noted at all treated  skin  sites 1 h  after  the  removal of the patches. Blanching of the skin was also noted at two of the skin sites. Eschar had developed at all treated skin sites at the 24 h observation and continued to be noted at the 48, 72 h and Day 7 observation. Blanching and moderate  erythema  extending  up to  approximately 7 cm beyond the treatment site were also noted at all the treated skin sites during this period. Scattered punctate eschar
surrounding two of the skin sites was also noted, with dry, straw-coloured skin evident at all the sites on Day 7. On Day 14  sunken  eschar  was  noted at all the treated skin sites. Severe oedema was noted at all the treated sites 1h after the removal of the patches. The oedema gradually decreased and appeared as very slight to slight on Day 7.  The oedema extended approximately 2 to 3 cm beyond all treated skin sites during this period. No oedema was noted on Day 14.

For result tables, kindly refer to the attached background material section of the IUCLID.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Under the study conditions, the test substance was found to be corrosive to skin in rabbits.

Executive summary:

A study was conducted to determine the skin irritation potential of the test substance, DDAC (80% active in hydroalcoholic solution), according to the OECD Guideline 404, in compliance with GLP. In the study, 0.5 mL test substance samples were applied under occlusive patches for both 3 and 60 min on the clipped skin of 3 rabbits. Residual test substance was removed using cotton wool soaked in 3% (v/v) aqueous acetic acid followed by distilled water. The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d. After 3 min exposure, very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 ad 48 h observations and at two treated sites at the 72 h observation. On Day 7 and 14, some hyperkeratinisation (2/3) and desquamation (1/3) was still present.After 1 h exposure, a light brown discolouration of the epidermis and slight haemorrhage of the dermal capillaries were noted at all treated skin sites 1 h after the removal of the patches. Blanching of the skin was also noted at two of the skin sites. Eschar had developed at all treated skin sites at the 24 h observation and continued to be noted at the 48, 72 h and Day 7 observations. Blanching and moderate erythema extending up to approximately 7 cm beyond the treatment site were also noted at all the treated skin sites during this period. Scattered punctuate eschar surrounding two of the skin sites was also noted, with dry, straw-coloured skin evident at all the sites on Day 7. On Day 14 sunken eschar was noted at all the treated skin sites. Severe oedema was noted at all the treated sites 1 h after the removal of the patches. The oedema gradually decreased and appeared as very slight to slight on Day 7. The oedema extended approximately 2 to 3 cm beyond all treated skin sites during this period. No oedema was noted on Day 14. Under the study conditions, the test substance was found to be corrosive to skin in rabbits (Guest, 1987).