2-Isobutyryl-3,N-diphenylacrylamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-05-29 to 1995-07-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline No. 406 under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

adopted 1992

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): BIBEA/A
- Expiry date: December 1996
- Storage: ambient, protected from light

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright white

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: not specified
- Weight at study initiation: male: 370-433 g; female: 365-498 g
- Housing: collective housing up to a maximum of 5 animals per cage (Makrolon type IV)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 30-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

other: various vehicles, see concentration

Challenge

Route:

epicutaneous, occlusive

Vehicle:

other: various vehicles, see concentration

No. of animals per dose:

Number of animals in test group: 20
Number of animals in negative control group: 10

Details on study design:

RANGE FINDING TESTS:
2 animals for range finding for intradermal injection
2 animals for range finding for dermal application

MAIN STUDY
A. INDUCTION EXPOSURE
Test group:
First stage - Intradermal three pairs of intradermal injections at the shoulders of the animals: 0.1 mL of a 5% dillution of the test article in peanut oil and 0.1 mL of a 5% dillution of thetest article in Freund's complete adjuvant/water and 0.1 mL of a 50% dillution of Freund's complete adjuvant in water
Second stage afer 7 days - dermal application at the shoulder of the animals: 50 % in Vaseline over an area 4x5cm for 48 h
Control group:
First stage - Intradermal three pairs of intradermal injections: 0.1 mL of peanut oil and 0.1 mL of a 50% dillution of Freund's complete adjuvant in water and 0.1 mL of a 50% dillution of Freund's complete adjuvant in peanut oil.
Second stage afer 7 days - dermal application: Vaseline over an area 4x5cm.
Both groups: 24 hours before the dermal application of the test article the area was treated with 10% sodium lauryl sulfate in vaseline to induce a mild inflammation.


B. CHALLENGE EXPOSURE (14 days after the second stage of induction)
Concentration of test material and vehicle used for each challenge in the test and the control group:
50% in vaseline to the left flank 100% vaseline to the right flank over an area of 5x5 cm.

Challenge controls:

The reaction to the positive control substance 2,4-dinitrochlorobenzene is tested periodically. The last test with acceptable levels of responses to this substance (mild or moderate sensitizer in dependence on the concentration) was performed from December 16, 1994 till January 9, 1995.

Positive control substance(s):

yes

Remarks:

2,4-dinitrochlorobenzene

Study design: in vivo (LLNA)

No. of animals per dose:

20 animals (10 male, 10 female) in the test group
10 animals (5 male, 5 female) in the control group

Statistics:

individual analysis according to the Draize system and report of the sensitizing rate in %

Results and discussion

Positive control results:

see above

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50 %

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

50 %

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test article BIBEA/A is a non-sensitizer under applied test conditions.

Executive summary:

The potential skin sensitizing properties of BIBEA/A were assessed in the guinea pig maximization test using 20 test and 10 control animals. Following induction exposure to the test article or the vehicle, the animals were subjected two weeks later to a challenge exposure with test article. The treated skin areas were evaluated 24 and 48 hours after the end of the exposure period. The sensitating rat was 0% at 24 and 48 hours.