Decyl dihydrogen phosphate, potassium salt

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October-November 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reported study with only basic data given; comparable to guideline/standard

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

no control group was used

GLP compliance:

no

Remarks:

pre-GLP

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

SInce a guinea pig maximisation study is already available, a LLNA study has not been performed

Test material

Test material information

Constituent 1

Reference substance name:

Decyl dihydrogen phosphate, potassium salt

EC Number:

270-390-7

EC Name:

Decyl dihydrogen phosphate, potassium salt

Cas Number:

68427-32-7

Molecular formula:

C10H23O4P.xK

IUPAC Name:

potassium decyl hydrogen phosphate

Details on test material:

Name of test compound: TL 522 45% a.s.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Redfern Animal Breeders Ltd., Brenchley, Kent, UK
- Age at study initiation: no info
- Weight at study initiation: no info
- Housing: suspended cages with wiremesh floor (no info on number per cage)
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: no info


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: From: October To: November 1974

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

Intradermal induction: 0.1% v/v
Topical induction: 10% v/v
Topical challenge: 5% v/v

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

Intradermal induction: 0.1% v/v
Topical induction: 10% v/v
Topical challenge: 5% v/v

No. of animals per dose:

10 (test group)

Details on study design:

RANGE FINDING TESTS: intradermal and topical irritancy was tested of a range of aqueous dilutions (no further info). 0.1% v/v and 10% v/v weres selected for intreadermal and topical induction, respectively.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single injection (with and without FCA) and topical application
- Exposure period: day 0 and day 7, respectively
- Test groups: yes
- Control group: not used
- Site: shoulder region
- Duration: single injection and 48 h occlusive application
- Concentrations: 0.1% v/v and 10% v/v, respectively

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 h occlusive
- Test groups: yes
- Control group: not used
- Site: flanks
- Concentrations: 5% v/v
- Evaluation (hr after challenge): 24, 48 and 72 h after patch removal

OTHER:
EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4

Challenge controls:

No controls were used

Positive control substance(s):

no

Results and discussion

Positive control results:

Not used

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5% v/v

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

see below

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: see below.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5% v/v

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Based on the results of the present test, although no control group was used, the test compound is not a sensitiser to guinea pig skin.

Executive summary:

A study was performed to assess the contact sensitisation potential of of the test material consisting of 45%decylphosphoric acid, potassium salt (CAS 68427-32-7) in the albino guinea pig. The study was performed essentially similar to the current OECD guideline 406; howver control animals were not used. Ten test animals were used for the main study. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:

lntradermal lnduction: 0.1% v/v

Topical Induction: 10% v/v

Topical Challenge: 5% v/v

The test material consisting of 45%decylphosphoric acid, potassium salt (CAS 68427-32-7) did not induce dermal irritation after the challenge application in any of the animals and was, therefore, classified as a non-sensitiser to guinea pig skin according to OECD-GHS.