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Description of key information

In a sensitisation study following the GPMT method as described in OECD 406, 20 guinea pigs were induced with two intradermal injections of Tetrabutan (10 % in maize oil) followed by a topical induction with 50 % test substance in maize oil. 10 control animals were similarly treated, except no test substance was applied. The induction administrations induced strong skin reactions including erythema, edema and subsequent crust formation. No reaction to 20 % test substance in maize oil was observed 24 and 48 hrs after the challenge treatment neither in the treatment group nor in the control group.Thus, Tetrabutan, dest. is not sensitising under the conditions of this test.

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
Study period:
20. Dec. 1988 - 13. Jan. 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report, which meets basic scientific priniciples
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The described guinea pig sensitisation test (Buehler test) according to OECD 406 was conducted in 1988 before the guidance for the LLNA (OECD429, first adopted in 2002) was available, and before the method was fully established and validated. And since the result of the Buehler test is considered to be scientifically valid, the test was not repeated also taking into account exposure and animal welfare considerations.
Species:
guinea pig
Strain:
other: DHPW, Albino guinea pig
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Weight at study initiation: mean 328 g
- Housing: 1-5 animals in macrolon cages Type IV
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
maize oil
Concentration / amount:
Tetrabutan, dest. 10 % in maize oil for intradermal induction
Tetrabutan, dest. 50 % in maize oil for epicutaneous induction
Tetrabutan, dest. 20 % in maize oil for challenge
Route:
epicutaneous, semiocclusive
Vehicle:
maize oil
Concentration / amount:
Tetrabutan, dest. 10 % in maize oil for intradermal induction
Tetrabutan, dest. 50 % in maize oil for epicutaneous induction
Tetrabutan, dest. 20 % in maize oil for challenge
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- Test groups: 20
- Control group: 10
- Site: both shoulders 4 x 6 cm
- Frequency of applications: 6
- Concentrations: Tetrabutan, dest. 10 % in maize oil


B. CHALLENGE EXPOSURE
- No. of exposures: 2
- exposure time challenge: 48 h
- exposure time rechallenge: 24 h
- Test groups: 20
- Control group: 10
- Site: both shoulders 4 x 6 cm
- Concentrations: Tetrabutan, dest. 50 % in maize oil
- Evaluation (hr after challenge):

Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
0
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
0
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 0.
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
0
Remarks on result:
no indication of skin sensitisation

Induction: after intradermal induction erythema and edema with necrotic areas were recorded at all injection sites with FCA. The same symptoms, but less severe, were also found for 10 % test substance and maize oil alone. The topical induction with 50 % Tetrabutan, dest. induced extensive inflammation, edema and subsequent crust formation.

None of the 20 guinea pigs of the treatment group and of the 10 animals of the control group showed skin reactions caused by the challenge treatment with Tetrabutan, dest. (20 % in maize oil).

Interpretation of results:
GHS criteria not met
Conclusions:
Tetrabutan, dest. was not sensitising under the test conditions. Thus, the available data on skin sensitization of Tetrabutan do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
Executive summary:

In a sensitisation study following the GPMT method as described in OECD 406, 20 guinea pigs were intradermally induced with Tetrabutan (10 % in maize oil) followed by a topical induction with 50 % test substanze in maize oil. 10 control animals were treated likewise, except no test substance was applied. The two-phased induction induced strong skin reactions like erythema, edema and subsequent crust formation. No reaction to 20 % test substance in maize oil was observed 24h and 48 h after the challenge treatment neither in the treatment group nor in the control group. Thus, Tetrabutan, dest. is not sensitising under the conditions of this test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Additional information:

There are no data on respiratory sensitisation for Tetrabutane. Inhalation exposure to Tetrabutane is unlikely because of the low vapour pressure of this material at standard temperature and pressure.


Migrated from Short description of key information:
No data

Justification for classification or non-classification

Tetrabutan, dest. was not sensitising under the conditions tested . Thus, the available data on skin sensitization of Tetrabutan do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.