Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test
Test material information:
Composition 1
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
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
TAME was applied as 100% solution
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
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

TAME was considered not sensitising in a guinea pig Bühler test performed according to USEPA Toxic Substance Control Act specification and under GLP (Pharmaco LSR, 1995). The incidence index in the positive control animals was 100%. None of the animals induced and challenged with TAME showed a dermal response, the incidence index and severity score being zero.


Migrated from Short description of key information:
Not a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Respiratory tract sensitisation is not expected as no positive human data are available suggesting that TAME causes respiratory tract sensitisation. In addition, no inflammatory changes indicative of respiratory tract sensitisation were reported in repeated exposure inhalation studies in animals.

Justification for classification or non-classification

Based on the available data, TAME is not a skin or respiratory tract sensitiser. In accordance with the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.