Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP guideline study, adequate for assessment. However, no analytical purity of the tested TAME sample was reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TAME
- Physical state: colorless liquid
- Lot/batch No.: MZ07905K2
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HPR, Inc.
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 357-555 gram
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 22 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-10-27 To: 1992-11-26

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
TAME was applied as 100% solution
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
TAME was applied as 100% solution
No. of animals per dose:
20 (10/sex)
Details on study design:
TAME was applied as 100% solution to twenty guinea-pigs (10/sex). The induction administration was done by placing an occluded chamber on the shaved back of the guinea-pig. About 0.3 ml of TAME was applied to the chamber, which was left in place for 6 hours. After the exposure period, the
chamber and any excess material were removed. The induction treatment was performed once a week and repeated for three times. Fourteen days
after the last induction exposure, the challenge was conducted in the same manner as in the induction phase, but on the opposite side of the back
midline. To control for irritation reactions at challenge, 10 (5/sex) previously untreated animals were subjected to the same challenge procedure as the animals, which received the induction treatment.

Light Mineral oil was used as control.
Challenge controls:
10
Positive control substance(s):
yes
Remarks:
DNCB

Results and discussion

Positive control results:
0.3% DNCB exhibited light irritation after the first induction. All ten positive control animals exhibited dermal responses greater in severity
(24 hours: 1.8 and 48 hours: 2.1) than those seen in the irritation control animals (0.2 and 1.4).The incidence index in the positive control animals
was 100%.

All ten control animals challenged with 100% light mineral oil were free of significant dermal responses, as were the irritation control animals.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100% TAME
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: 100% TAME. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100% TAME
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: 100% TAME. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion