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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Short report of modified guideline study. No data on substance purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
10 rather than 20 test animals. Modified exposure pattern.
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
Study performed before the adoption of the OECD 429 guideline

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TBEP Tenneco Chemicals Inc.
- Analytical purity: no data
- Impurities (identity and concentrations): no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 300-400g
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 7 March 1980 To: 11 April 1980

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml at 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml at 100%
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24h
- Test groups: 10 animals
- Control group: no data
- Site: no data
- Frequency of applications: alternate days
- Duration: 19 days
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 33
- Exposure period: 24 h
- Test groups: 10
- Control group: no data
- Site: different from induction site
- Concentrations: 100%
- Evaluation (hr after challenge): 24h

OTHER:
Challenge controls:
No data
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
other: no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
TBEP did not elicit any evidence of sensitization under the conditions of this test.
Executive summary:

In a modified Buehler test, 10 albino guinea pigs were exposed to TBEP. A 0.5 ml portion of test material was applied to the intact skin test sites. A gauze patch was placed over the treated area and an impervious material was wrapped snugly around the trunks of the animals. After a 24 hour contact period, the patch was removed and the animals were allowed to rest for one day. Following the rest period, another application was made to the same skin site using a fresh test sample. This sequence was repeated for a total of ten applications. The animals were then rested for two weeks. At the end of the rest period, a challenge application was made to a fresh skin site and left on the skin for 24 hours. 24 hours after each induction stage application and 24 and 48 hours after the challenge application, the sites were examined for irritation, using the Draize method of scoring.

There were no signs of irritation at any of the test sites during induction or at challenge. It was concluded that  TBEP was not a primary skin irritant or sensitizing agent in the albino guinea pig.