Ethanone, 1,2-diphenyl-, oxime

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 November 1997 - 05 January 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed in a GLP laboratory in accordance with EPA OTS guidelines. One deviation was noted but was not considered to have had an adverse effect on the outcome of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4100 (Skin Sensitisation)

Deviations:

yes

Remarks:

Not considered to have had an adverse effect on the outcome of the study.

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-N-(1,2-diphenylethylidene)hydroxylamine

EC Number:

811-357-4

Cas Number:

952-06-7

Molecular formula:

C14 H13 N O

IUPAC Name:

(Z)-N-(1,2-diphenylethylidene)hydroxylamine

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): SC-66276
- Physical state: white powder

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Crl:(HA)BR/Covance Research Products Inc. -

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: harles River Laboratories, Inc.
- Age at study initiation: Young Adult
- Weight at study initiation: 350 - 550 g
- Housing: were individually housed in suspended, stainless steel cages:
- Diet (e.g. ad libitum): continuous access to Certified Guinea Pig Diet #5026, PMI Feeds, Inc.
- Water (e.g. ad libitum): continuous access to water.
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18° to 26°C
- Humidity (%): 50% ±20%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

petrolatum

Induction 2

Concentration / amount:

25% w/w mixture of test material in petrolatum

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

25% w/w mixture of test material in petrolatum

No. of animals per dose:

20 animals for test group, 10 animals for control group.

Details on study design:

RANGE FINDING TESTS:
The test material concentrations were placed on 2-cm x 2-cm pieces of filter paper in a
thick even layer secured to the animals and allowed to remain in place for approximately
24 hours. The test sites were overwrapped with strips of Blenderm™ tape and secured with
Elastoplast® tape in the same manner as if for a challenge application. The sites· were
scored for erythema and edemaat approximately 24 and 48 hours after patch removal.
The test sites were clipped with an electric dipper before the first reading. The
surviving animals were then be sacrificed and discarded after the 48 hour score.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three per test animal, anterior, medial and posterior sites.
- Test groups: one test group and one control
- Site: anterior, medial and posterior sites.
- Concentrations: Test group
Anterior Sites (1:1 dilution Freund's Complete Adjuvant in sterile water);
Medial Site (5% w/v suspension of test material in mineral oil);
Posterior Sites (5% w/v suspension of test material in FCA in sterile water)
- Concentrations: Control Group
Anterior Sites (1:1 dilution Freund's Complete Adjuvant in sterile water);
Medial Site (vehicle, mineral oil);
Posterior Sites (1:1 dilution of mineral oil in FCA)

B. CHALLENGE EXPOSURE
- No. of exposures: two per animal, test substance was placed on the right-hand-side, control was placed on left-hand-site.
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- Test groups: test group, 20 animals
- Control group: 10 animals
- Site: 5-cm x 5-cm sites on left and right hand side of each animal.
- Concentrations: 1 %, 10%~ 15%, and 25% w/w in petrolatum
- Evaluation (hr after challenge): 24 and 48 hours.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25% (w/w)

No. with + reactions:

1

Total no. in group:

20

Clinical observations:

One animal exhibited mild scattered redness.

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (w/w). No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: One animal exhibited mild scattered redness..

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25% (w/w)

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

None.

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None..

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

For the definitive test, animals in the SC-66276 and control groups appeared clinically
normal and exhibited body weight gain throughout the study, with the exception of one
animal from the control group which appeared thin on Day 24 and exhibited a slight body
weight loss (4 grams; 0.8% relative to pretreatment weight).
None of the animals in the SC-66276 and control groups exhibited dermal reactions to the
SC-66276 or control material at challenge, with the exception of one SC-66276 animal
which exhibited a mild dermal reaction to the challenge application of the test material.
In conclusion, based on the findings of this study, relative, to those observed historically
with a known sensitizer, SC-66276 is considered to be a weak dermal sensitizer in guinea
pigs when tested by the Magnusson and Kligman maximization assay.

Executive summary:

Test substance (SC-66276) is considered to be a weak dermal sensitizer in guinea pigs when tested by the Magnusson and Kligman maximization assay but not sufficient for classification according to EU CLP.