Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate

EC Number:

287-619-1

EC Name:

Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate

Cas Number:

85563-48-0

Molecular formula:

C20H44NO.H2O4P

IUPAC Name:

dihydrogen hexadecyl(2-hydroxyethyl)dimethylazanium phosphate

Test material form:

other: liquid

Details on test material:

- yellowish

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- SPF
- Animal supplier: Dr. K. Thomae GmbH, Biberach
- Acclimatization period: at least one week
- Young adult animals were used; mean body weight females 3.74 kg, male 3.62 kg
- Singly housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2.
- No bedding in the cages, dawdust in the waste trays
- The animals were identified via ear tattoo.
- The rabbits were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
- The animals were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

The test patches (2.5 x 2.5 cm) were moistened with a dose of 0.5 ml.

Duration of treatment / exposure:

4 hours

Observation period:

15 days

Number of animals:

3

Details on study design:

At least 24 hours before study start, the fur of the rabbits was removed by clipping the dorsal of the trunk of the animals. Only animals with healthy intact skin have been used.
Weight determination: shortly before application
The test substance was applied in a singly dose ot the intract untreated skin. The test patch was secured in position with a semiocclusive dressing. The test substance was removed at the end of the application period with Lutrol and Lutrol/water (1:1).
Application site: upper third of the back or flanks
Readings: 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after removal of the test patch
A check was for general observations and dead resp. moribund animals was made twice each working day and once on weekends and on public holidays.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Slight erythema still visible, scaling observed in all animals on day 15.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.1

Max. score:

4

Reversibility:

fully reversible within: 15 d

Irritant / corrosive response data:

Erythema mean values per animal (24-72h):
1) 3.7
2) 2.7
3) 3.7

Edema mean values per animal (24-72h):
1) 3.0
2) 1.3
3) 2.0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions chosen the test item gives indication of an irritant property to the skin.

Executive summary:

The potential of the test item to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 white New Zealand rabbits for 4 hours under semi-occlusive dressing.

The average score (24 to 72 h) for irritation was calculated to be 3.3 for erythema and 2.1 for edema. Signs of skin irritation (such as edema) were reversible within 15 days after removal of the patches, while erythema and scaling were still present at study termination. Symptoms observed indicate an irritant property of the test item to the skin.