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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP, but the report contains sufficient data for interpretation of study results.
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:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Following exposure, observations and body weights were recorded over a 2-week period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material: Dowfax 2A1
Source: Specialty Chemicals, The Dow Chemical Company
Properties: Amber liquid
pH= 7.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
No additional data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 male rabbits/dose
Control animals:
no
Details on study design:
In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat Dowfax 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Following exposure, observations and body weights were recorded over a 2-week period.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a slightly abraded site (minor incision through the stratum corneum of insufficient depth to produce bleeding), caused only very slight imtation to the skin, it is felt that these burns may be a result of the procedure used in preparing the animals for testing. These observations were noted through test day four in one animal, and test day eight in the other. By test day eight, both animals were observed with scaling, which persisted through the end of the study.
Body weight:
Administration of DOWFAX 2A1 at 2000 mg/kg had no apparent effect on body weight during the two week observation period.
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.
Executive summary:

A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a slightly abraded site (minor incision through the stratum corneum of insuffiaent depth to produce bleeding), caused only very slight irritation to the skin, it is felt that these burns may be a result of the procedure used in preparing the animals for testing. These observations were noted through test day four in one animal, and test day eight in the other. By test day eight, both animals were observed with scaling which persisted through the end of the study. Administration of DOWFAX 2A1 at 2000 mg/kg had no apparent effect on body weight during the two-week observation period. The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.