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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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
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:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
An acute dermal toxicity study was performed in albino rabbits. The test material was applied topically via a 24 h occlusive patch and observations were made for a period of seven days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: Clear colourless liquid
- Other: BRL No. 590A

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: Rubber dam, held in place by tape.
- Other: Animals were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified and in half of the animals the area was lightly abraded.


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
0.315, 0.795, 1. 99 and 5.0 mL/kg bw
No. of animals per sex per dose:
4 per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 d
- Necropsy of survivors performed: Yes
Statistics:
No data

Results and discussion

Preliminary study:
No
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 4.7 mL/kg bw
Remarks on result:
other: equivalent to 5170 mg/kg bw assuming density of test material as 1.1 g/mL
Mortality:
One each in 1.99 and 5.0 mL/kg bw dose groups
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
- Other observations (skin irritation): In some cases, the test material caused no erythema or edema, but in others caused severe effects.

Any other information on results incl. tables

Table 1: Number of observed mortalities:

Dosage (mL/kg bw) Mortality
0.315 0/4
0.795 0/4
1. 99 1/4
5 1/4

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be 4.7 mL/kg bw (i.e. 5170 mg/kg bw) in rabbits. Therefore no classification is required according to the EU CLP criteria.
Executive summary:

A study was conducted to evaluate the acute dermal toxicity of the test substance (trimethylolpropane triacrylate - TMPTA) in rabbits.

Sixteen albino rabbits were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified and in half of the animals the area was lightly abraded. After weighing the animal, the calculated dose was applied and the entire area covered with a rubber dam, held in place by tape. The dose levels applied were 0.315, 0.795, 1.99 and 5.0 mL/kg bw the test substance (trimethylolpropane triacrylate - TMPTA).

Four animals were included in each dose group. 24 h later, the binders were removed and an effort made to remove any remaining material from the skin surface. A score of the local effects, according to the method of Draize, was recorded. The animals were observed repeatedly for seven days at the end of which time they were killed and necropsy was performed.

One mortality was observed at dose levels 1.99 and 5.0 mL/kg bw. In some cases, the test substance (trimethylolpropane triacrylate - TMPTA)

caused no erythema or edema, but in others caused severe effects.

In conclusion, the single dermal median lethal dose (LD50) of the test substance (trimethylolpropane triacrylate - TMPTA) was determined to be 4.7 mL/kg bw (i.e. 5170 mg/kg bw) in rabbits.