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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-25 to 2008-08-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1993
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted before the LLNA was established as standard in vivo method.

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphoric acid, butyl ester, sodium salt
EC Number:
258-380-0
EC Name:
Phosphoric acid, butyl ester, sodium salt
Cas Number:
53126-67-3
Molecular formula:
C4H11O4P.Na
IUPAC Name:
Phosphoric acid, butyl ester, sodium salt
Test material form:
liquid

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 GmbH
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 5-6 weeks at beginning of acclimatisation
- Weight at study initiation: 332 g-362 g
- Housing: Individually in Makrolontype-4 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz / Switzerland)
- Diet: Pelleted standard Provimi Kliba 3418 guinea pig breeding / maintenance diet batch no. 27108, containing Vitamin C (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland), ad libitum
- Water: tap water ad libitum
- Acclimation period: Under laboratory conditions after health examination. No acclimatization for the animals of the pretest.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
50 % and 100 % test item were selected for the intradermal induction and the epidermal induction, respectively.
Day(s)/duration:
intradermal injection on day 1, epidermal injection on day 8
Adequacy of induction:
other: The concentration of test item used for each induction exposure was well-tolerated systemically and was the highest to cause mild to moderate skin initation.
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
15 %
Day(s)/duration:
test day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 animals in control group
10 animals on test group
Details on study design:
RANGE FINDING TESTS:
The concentrations of the test item required for the induction and challenge were selected based on the results of a preliminary study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (one intradermal and one epidermal)
- Exposure period: epidermal exposure for 48 hours (occlusive dressing)
- Test groups: one test group
- Control group: control group treated with water (vehicle)
- Site: intradermal injection: An area of dorsal skin from the scapular region (approximately 6 x 8 cm), 3 pairs of injuections,
epidermal exposure: scapular area (approximately 6 x 8 cm)
- Concentrations: intradermal induction of sensitization in the test group was performed with a 50 % dilution of the test item in purified water and in an emulsion of Freund's Complete Adjuvant (FcA)/physiological saline.
epidermal induction: 100 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 22 of the experiment
- Exposure period: dressings were left in place for 24 hours
- Test groups: The test and control guinea pigs were treated in the same way.
- Site: 5 x 5 cm area on the left and right flank
- Concentrations: 15 % ( left flank), water only (right flank)
- Evaluation (hr after challenge): 21 h after reomval of the dressing, 48 h and 72 h after start of challenge exposure
Challenge controls:
none
Positive control substance(s):
yes
Remarks:
ALPHA-HEXYLCINNAMALDEHYDE

Results and discussion

Positive control results:
Discrete/patchy to moderate/confluent erythema with or without scaling was observed in nine out of ten test animals at the 24- and 48-hour reading after the challenge treatment with ALPHA-HEXYLCINNAMALDEHYDE at 1 % in PEG 300 (left shoulder). Five test animals showed discreteþatchy erythema at the 24-hour reading after treatment with ALPHAHEXYLCINNAMALDEHYDE at 0.1% in PEG 300 (left flank).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 (right flank)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no abnormalities
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 (right flank)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no abnormalities
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
15 % test item (left flank)
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no abnormalities
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
15 % test item (left flank)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no abnormalities
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 (rigth flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormalities
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 (right flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormalities
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
15 % test item (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormalities
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
15 % test item (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormalities
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no abnormalities
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1 %
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
no abnormalities
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the fïndings in the adjuvant sensitization test in guinea pigs the test substance does not have a skin sensitising potential.
Executive summary:

In order to assess the cutaneous allergenic potential of the test substance, a Maximization-Test was performed in 15 (10 test and 5 control) female albino Dunkin Hartley guinea pigs, in accordance with OECD Guideline No. 406 and the Council Regulation (EC) No 44012008,8.6. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 50 % dilution of the test item in purified water and in an emulsion of Freund's Complete Adjuvant (FcA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 100 % one week after the intradermal induction. The animals of the control group were intradermally induced with purifred water and FCA/physiological saline and epidermally induced with purified water under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 15 % in purified water and purified water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No toxic signs were evident in the guinea pigs of the control or test group. No deaths occurred. No positive/skin reactions were observed in the control and test animals when treated with either purified water only or when treated with the test item at 15 % in purified water.

Based on the above mentioned fïndings the substance does not have to be classified and labelled as a skin sensitizer.