2-ethylhexyl diphenyl phosphate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

100 males and 100 female subjects were exposed twice (13 days rest period between treatment) for 48 hours on the upper arm using an occluded patch (impregnated paper). Skin reactions were scored at 0, 24 and 48 hours after removal of the patch to determine the sentising potential of the test substance.

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

Human study available

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl diphenyl phosphate

EC Number:

214-987-2

EC Name:

2-ethylhexyl diphenyl phosphate

Cas Number:

1241-94-7

Molecular formula:

C20H27O4P

IUPAC Name:

2-ethylhexyl diphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): Santicizer 141
- Physical state: Liquid

In vivo test system

Test animals

Species:

human

Strain:

other: Not relevant

Sex:

male/female

Details on test animals and environmental conditions:

Not relevant, human study

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

Unknown (applied as received)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

Unknown (applied as received)

No. of animals per dose:

200 human subjects

Details on study design:

Not relevant, human study

Challenge controls:

Not relevant, human study

Positive control substance(s):

not required

Remarks:

human study

Results and discussion

Positive control results:

Not relevant, human study

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

other: all readings after induction

Group:

test chemical

Dose level:

Not available

No. with + reactions:

30

Total no. in group:

200

Clinical observations:

Score of 1: 18 subjects, score of 2: 12 subjects

Remarks on result:

other: Reading: other: all readings after induction. Group: test group. No with. + reactions: 30.0. Total no. in groups: 200.0. Clinical observations: Score of 1: 18 subjects, score of 2: 12 subjects.

Remarks:

Dose levels not available

Results 2

Key result

Reading:

other: all readings after challenge

Group:

test chemical

Dose level:

Not available

No. with + reactions:

29

Total no. in group:

200

Clinical observations:

Score of 1: 18 subjects, score of 2: 11 subjects

Remarks on result:

other: Reading: other: all readings after challenge. Group: test group. No with. + reactions: 29.0. Total no. in groups: 200.0. Clinical observations: Score of 1: 18 subjects, score of 2: 11 subjects.

Remarks:

Dose levels not available

Any other information on results incl. tables

30 out of 200 subjects (20 female) showed positive skin reactions at 1 of the 3 readings after induction. At the challenge phase, 29 out of 200 subjects (again 20 female) showed a positive skin reaction at 1 of the 3 readings. Only 1 human subject showed an additional positive skin reaction at the challenge readings, while in 2 other subjects the reaction disappeared.

Due to the high level of skin reactions after the induction phase (comparable to that in de challenge phase), the substance can be considered rather irritating than sensitising.

The reactions on the skin cleared without incident within 10 days after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:

ambiguous

Remarks:

Migrated information

Conclusions:

Under the conditions of this study, it was not possible to conclude on the sensitising potential of Santicizer 141, as the substance can be considered rather irritating than sensitising.

Executive summary:

100 males and 100 female subjects were exposed twice (15 days rest period) for 48 hours on the upper arm using an occluded patch (impregnated paper). Skin reactions were scored at 0, 24 and 48 hours after removal of the patch to determine the sensitising potential of the test substance.

30 out of 200 subjects showed positive skin reactions at 1 of the 3 readings after induction. At the challenge phase, 29 out of 200 subjects showed a positive skin reaction at 1 of the 3 readings. Only 1 human subject showed an additional positive skin reaction at the challenge readings, while in 2 other subjects the reaction disappeared.

Under the conditions of this study, it was not possible to conclude on the sensitising potential of Santicizer 141, as the substance can be considered rather irritating than sensitising.