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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-03-15 until 2005-04-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
adopted 1996-07-30
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted 1992-07-17
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The guinea pig test method described in OECD TG 406 provides suitable information for hazard identification.

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium hexadecyl hydrogen phosphate
EC Number:
242-768-1
EC Name:
Potassium hexadecyl hydrogen phosphate
Cas Number:
19035-79-1
Molecular formula:
C16H35O4P.K
IUPAC Name:
potassium hexadecyl hydrogen phosphate
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg Germany
- Weight at study initiation: mean weight 381 g
- Housing: Individually in transparent macrolon cages (type IV) on soft wood granulate in on air-conditioned room. 3 or 2 animals per cage
- Diet: ssniff Ms-H (V 2233), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours light / dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
Induction (epicutaneous): 100 % (moistened)
Challange (epicutaneous): 100 % (moistened)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
Induction (epicutaneous): 100 % (moistened)
Challange (epicutaneous): 100 % (moistened)
No. of animals per dose:
Experimental group: 20 females guinea pigs
Control group: 10 females guinea pigs
Details on study design:
PRE-TEST:
A pre test was performed in order to determine the non-irritating concentrations of the test substance. No irritation signs (oedema or erythema) were observed with the 100 % (moistened) test substance.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Day 1, Day 8 and Day 15 (6 hours each)
- Test group: treated with 100 % (moistened) test substance
- Control group: treated with the vehicle
- Site: flank
- Frequency of applications: once a week
- Concentrations: 100 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 29 days after epidermal induction exposure
- Exposure period: 6 hours
- Test group: single treatment
- Control group: single treatment
- Site: flank
- Concentrations: 100 %
- Evaluation (hr after challenge): 24, 48 hours
Positive control substance(s):
yes
Remarks:
Alpha-hexylemnamaldhyde (50% in PEG-40)

Results and discussion

Positive control results:
The validity of the test system is confirmed by periodically conducted positive control test using in the testing laboratory. The positive control results attached to the report showed the expected positive results.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, none of the twenty animals of the treatment group showed a positive skin response after the challenge procedure. Thus, the percentage of animals reacting positive is below the threshold of 15 %. Based on the results of this study the test substance showed no evidence for sensitizing properties.
Executive summary:

Skin sensitization testing of the test substance was performed in female guinea pigs in the BUEHLER method B.6 according to EU Method and OECD guideline 406. Dermal induction was performed using 100 % of the test substance moistened with 0.3 mL in sesame oil. The control group was exposed to sesame oil only during induction phase. Challenge treatment was carried out with 100 % of the test substance moistened with 0.3 mL in sesame oil. The validity of the test system was confirmed by a periodically conducted positive control test using Alpha-hexylcinnamaldehyde in a maximization test in the testing laboratory. Based on the results of this study the test substance showed no evidence for sensitizing properties.