Tributylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1974

Report date:

1974

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1962

Report date:

1962

Reference 3

Reference Type:

publication

Title:

Unnamed

Year:

1954

Report date:

1954

Materials and methods

Principles of method if other than guideline:

Method: acute dermal toxicity
Screening acc. to Smyth et al., 1962 and Smyth et al., 1954.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tributylamine

EC Number:

203-058-7

EC Name:

Tributylamine

Cas Number:

102-82-9

Molecular formula:

C12H27N

IUPAC Name:

tributylamine

Details on test material:

- Name of test material (as cited in study report): Tributylamine

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: 1/10 of the body surface
- Type of wrap if used: plastic film

Duration of exposure:

24 h

Doses:

not stated

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

195 mg/kg bw

Any other information on results incl. tables

LD50 value is given as 0.25 ml/kg bw (conversion to mg/kg bw was done using the density d= 0.78 g/ccm). Fiducial range values (+/- 1.96 S.D.) were from about 120 - 316 mg/kg bw.

No further data e.g. on clinical signs or body weight were recorded.

Applicant's summary and conclusion

Interpretation of results:

Category 2 based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing for acute dermal toxicity led to a LD50 = 195 mg test item (Tributylamin) per kg bw. Due to this value the results were interpreted.

Executive summary:

Male white New Zealand rabbits (4 animals/dose) were subjected to test acute dermal toxicity. The test item (purity not stated) was applied onto 1/10 of the body surface for 24 h under occlusive conditions. The effects were observed for further 14 days.

This single application of the test item to male New Zealand rabbits resulted in a LD50 = 195 mg/kg bw (Carpenter et al., 1974).

This acute dermal toxcicity study is performed well and basic data are given, thus the study can be juged reliable with restrictions (RL 2).