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Toxicological information

Acute Toxicity: dermal

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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:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1974
Report Date:
1974
Reference Type:
publication
Title:
Unnamed
Year:
1962
Report Date:
1962
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

Reference
Name:
Unnamed
Type:
Constituent
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 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).