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Diss Factsheets

Administrative data

Description of key information

The test item revealed no skin sensitizing properties in a Buehler test and an open epicutaneous study performed according to OECD guideline 406. Results of the animal studies are in line with results obtained from a patch test performed with human subjects.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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

Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
Induction (epicutaneous): 100 % (moistened)
Challange (epicutaneous): 100 % (moistened)
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)
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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 during the induction phase. 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. (Aventis, 2000)

The skin sensitisation study on guinea pigs was performed according to OECD guideline 406. For induction, 0.1 mL of the test substance was applied to the shaved flank of the test animals in concentrations of 10, 30, 50, and 70 % of the test substance diluted in water for three weeks (5 times per week). One week after the last induction the animals were challenged at the contralateral flank with 0.025 mL of a 50 % solution of the test substance. An additional 18 animals (control group) also received 0.025 mL of the test substance for challenge without previous induction. Observations for skin reactions were recorded approximately 24 hours after challenge application. Rechallenge was conducted 7 days after the first challenge phase. All animals remained healthy and gained weight during the study. One male died spontaneously on day 24 of the test, but this was not considered treatment related. Repeated applications of 10 % and 30 % concentrations of the test substance were well-tolerated on the guinea pig skin when application sites had been changed weekly, while higher concentrations (50 % and 70 %) caused moderate to strong skin irritation in 1/6 experimental animals of each of the two groups. Challenge tests with 10 %, 30 %, 50 % and 70 % concentrations of the test substance elicited no allergic sensitisation. (RCC, 1987)

The results of the animal studies were supported by the results of a repeated insult (occlusive) patch test procedure in human subjects with 6 % of the test substance (see section 7.10.4). The study showed that the test substance does not induce irritant or allergic contact dermatitis in human subjects.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results obtained, potassium hexadecyl hydrogen phosphate was not classified and labelled for dermal sensitisation, according to Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.