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Diss Factsheets

Administrative data

Description of key information

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:
1997-09-17 to 1997-10-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992-07-17
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH -Wiga, Kisslegg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 330-392 g
- Housing: 5 animals per cage, cage-type: Makrolon type IV
- Diet: Kliba Labordiät ad libitum
- Water: tap water ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21-25
- Humidity (%):30-70
- Photoperiod (hrs dark / hrs light):12/12
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
1st, 2nd and 3rd induction: test substance 25% in olive oil
Challenge and re-challenge: test substance 10 % in olive oil
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
1st, 2nd and 3rd induction: test substance 25% in olive oil
Challenge and re-challenge: test substance 10 % in olive oil
No. of animals per dose:
10 (controls); 20 (test group)
Details on study design:
RANGE FINDING TESTS:
3 animals per test concentration, 6 hours exposure, application frequency 2 times o the same area (one apllication per week)

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site:anterior left flank
- Frequency of applications:one application per week; days 0,7 and 14


B. CHALLENGE EXPOSURE
- No. of exposures:2
- Day(s) of challenge:a challenge was carried out 14 days after the third induction, a rechallenge one week after the challenge
- Exposure period: 6 hours
- Site: Challenge: test substance formulation: anterior right flank, vehicle: posterior right flank;
Rechallenge: test substance formulation: anterior left flank, vehicle: posterior left flank
- Concentrations: 10 % in olive oil
- Evaluation:24 and 48 h after challenge
Positive control substance(s):
yes
Remarks:
Alpha-Hexylcinnamaldehyde
Positive control results:
Based an the results of the study under the test conditions chosen Alpha-Hexylcinnamaldehyde techn. 85% has a sensitizing effect an the skin af the guinea pig strain usecl (Pirbright White Dunkin Hartley Cr1: (hA) BR [SPF]; Charles River GmbH-Wiga, Kisslegg, Germany, in the BUEHLER Test.
Reading:
other: 1st challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
discrete or patchy erythema, moderate + confluent erythema, in some animals with swelling + intense erythema + swelling.
Remarks on result:
other: see Remark
Remarks:
Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema, moderate + confluent erythema, in some animals with swelling + intense erythema + swelling. .
Reading:
other: 1st challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
discrete or patchy erythema, moderate and confluent erythema, in some animals with swelling.
Remarks on result:
other: see Remark
Remarks:
Reading: other: 1st challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema, moderate and confluent erythema, in some animals with swelling..
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
discrete or patchy erythema and moderate and confluent erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema and moderate and confluent erythema .
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
discrete or patchy erythema and moderate and confluent erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema and moderate and confluent erythema.
Reading:
other: 1st challenge
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
1 animal reacted to the vehicle alone
Remarks on result:
other: Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 1 animal reacted to the vehicle alone.
Reading:
other: 1st challenge
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
2 animals reacted to the vehicle alone
Remarks on result:
other: Reading: other: 1st challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 2 animals reacted to the vehicle alone.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
No reactions to the vehicle alone were observed.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No reactions to the vehicle alone were observed..
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
No reactions to the vehicle alone were observed.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No reactions to the vehicle alone were observed..
Interpretation of results:
sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The substance Diethoxyphenylphosphin was tested for its sensitizing effect on the skin of the guinea pig in the BUEHLER Test based on the method af BUEHLER, E.V. (1965) and according to OECD 406 (BASF 1998).

The lowest minimal irritant dose used for the three inductions was 25%. Erythema and in some cases swelling were observed after the second and third induction in control and test animals. As also determined in a pretest, the highest non-irritant concentration was 10%, which was used for two challenges performed 14 and 21 days after the last induction.

1 of 10 control animals reacted to the rechallenge, but not during challenge, with the test substance. In the test group, 13 of 20 animals showed a positive reaction after 24h after the challenge application. After 48h, a positive skin reaction was observed in 11 animals. Rechallenge led to skin reactions in 9 animals after 24h and in 11 animals after 48h. Based an the results of this study it was concluded that Diethoxyphenylphosphin has a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.


Migrated from Short description of key information:
BUEHLER Test: positive (GLP, OECD 406, BASF 1998)

Justification for selection of skin sensitisation endpoint:
only one reliable GLP and guideline study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results of the BUEHLER Test show that Diethoxypheriylphosphin has a sensitizing effect on the skin of the guinea pig. According to Regulation (EC) No 1272/2008 (CLP), the test substance has to be classified into category 1B, H317 ( May cause an allergic skin reaction).

According to Directive 67/548/EEC (DSD), the substance has to be classified as Xi, R43 (May cause sensitisation by skin contact).