Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 13, 1984 to April 11, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Principles of method if other than guideline:
An acute dermal toxicity study was performed in rabbits. The test material was administered at a single dose level and observations were made for a period of 7 d.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Substance type: Pure active substance
- Physical state: Very light amber liquid
- Analytical purity: 100 %
- Storage condition of test material: 15.55-29.44 °C
- Other: Density: 1.1 g/mL

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
IN-LIFE DATES: From: 1984-02-13 to: 1984-08-03

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 12000 mL/kg bw
Duration of exposure:
No data
Doses:
13200 mg/kg bw
No. of animals per sex per dose:
Four
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 d
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 13 200 mg/kg bw
Mortality:
None
Clinical signs:
Lack of food consumption was reported in one animal on days 5 and 6.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of ethoxylated trimethylolpropane triacrylate (TMPeoTA) was determined to be >13,200 mg/kg bw in rabbits.

Executive summary:

A study was conducted to evaluate the acute dermal toxicity of ethoxylated trimethylolpropane triacrylate (TMPeoTA) in albino rabbits. A dermal application of 13,200 mg/kg TMPeoTA was applied to 4 rabbits. Parameters evaluated included mortality, clinical observations and body weight for a period of 7 days. No mortality was observed. Lack of food consumption was reported in one animal on days 5 and 6.

In conclusion, the single dermal median lethal dose (LD50) of TMPeoTA was determined to be >13,200 mg/kg bw in rabbits.