Tris(2-butoxyethyl) phosphate

Skin sensitisation

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

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

Test material information

Constituent 1

Reference substance name:

Tris(2-butoxyethyl) phosphate

EC Number:

201-122-9

EC Name:

Tris(2-butoxyethyl) phosphate

Cas Number:

78-51-3

Molecular formula:

C18H39O7P

IUPAC Name:

tris(2-butoxyethyl) phosphate

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)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

0.5 ml at 100%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

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)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

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.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

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.

Results 3

Group:

negative control

Remarks on result:

not measured/tested

Results 4

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.