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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1986 - August 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performerd under GLPs using an established methodology (Buehler).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Principles of method if other than guideline:
Group sizes were 20 animals for the test group and 10 animals for the naive control group. Approximately 2 weeks after the last induction session, the test material prepared as a 50% w/v formulation in acetone was reapplied to the test animls for 5 and 3/4 hours. The test material was also applied to 10 naive control animals. The next day the sites were depilated and scored for severity of response 24 and 48-hrs after removal of the patches.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Endpoint addressed using pre-existing data,dating from 1986.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test article was the commercial Saytex RB-49 product, and applied as a 95% formulation in acetone to the backs of male and female Hartley guinea pigs for 3 six-hour periods at weekly intervals.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Hartley albino guinea pigs from Murphy Breeding Laboratories, Inc. were used (275-350 g). Animals were acclimated for 7 days after arrival at the test laboratory. Tap water and Purina Guinea Pig Chow were available ad libitum. Animals were housed singly in wire mesh suspension cages and maintained on a 12/12 hr light/dark cycle. Animals were identified by numbered cage cards.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
95% w/v formulation
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
95% w/v formulation
No. of animals per dose:
10M/10F in the test group. 5M/5F in the naive control-primary challenge group. 5M/5F in the naive control rechallenge group.
Details on study design:
Prior to induction and challenge, the test material was tested for primary irritation in guinea pigs as 95%, 50%, 25% and 10% w/v formulations in acetone. On the day before application, the animals' backs were clipped with electric clippers. On the following day, animals were placed in stainless steel restrainers and patches were applied to each animal. The patches, incorporating a 25 mm Hill Top Chamber, were moistened with 0.3 ml of one of the test formulations. The patches were occluded with dental dam placed over the back of each animal and secured with metal clips. The animals were restrained for 6 hrs and returned to their cages. On the following day, the clipped areas were depilated with NEET CREAM HAIR REMOVER. The cream remained in place for 8 minutes afterwhich it was removed with warm tap water. The patch sites were were scored at 24- and 48hrs without additional depliation using the following scale: 0=no reaction; +=slight patchy erythema (Grades of +/- are equal to 0.5 for calculating the mean); 1=slight confluent or moderate patchy erythema; 2=moderate erythema, 3=severe erythema with or without edema. The test material as a 95% w/v formulation in acetone was chosen for induction, while a concentration of 50% w/v in acetone was chosen for primary challenge.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Grade 1 reactions in 5 animals.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Grade 1 reactions in 5 animals..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Grade 1 reactions in 5 animals.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Grade 1 reactions in 5 animals..
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Grade 1 reactions in 2 animals.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Grade 1 reactions in 2 animals..

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test material induced skin sensitization in guinea pigs under the conditions of the test.
Executive summary:

TBPA was positive for skin sensitization when tested in the Buehler guinea pig test.