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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:
not specified
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:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute study followed the method of Draize.

Draize, J.H., G. Woodard, and H.O. Calveri.: Methods for Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Therap. 82:377-390
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
ERL-2774
Purity- no data in report

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
Male albino New Zealand rabbits, 3 to 5 months of age and averaging 2.5 kg. in weight were immobilized during the 24-hour skin contact period. Thereafter, the VINYLITE sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were caged for the remainder of the 14-day observation period. The rabbits were procured locally and maintained on Rockland rabbit ration.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious sheeting.
Duration of exposure:
24 hour
Doses:
up to 20ml/kg
No. of animals per sex per dose:
4 male rabbits/dose
Control animals:
not specified
Details on study design:
Penetration of rabbit skin is estimated by a technique resembling a one-day cuff method of Draize, using groups of 4 male albino rabbits weighing 2.5 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious sheeting. Doses greater than 20 ml/kg could not be retained in contact with the skin. The animals were immobilized for the 24-hour period, after which the film is removed and the rabbits were caged for the subsequent 14-day observation period. The LD50 was then calculated using the method of Thompson.
Statistics:
The LD50 was then calculated using the method of Thompson.

Thompson, W. R.: Use of Moving Averages and Interpolation to Estimate Median Effective Dose. Bacterial Rev. 11:115 (June 1947).

Results and discussion

Preliminary study:
No preliminary study conducted.
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Remarks on result:
other: Dose was calculated to be 23,032 mg/kg from the reported dose of 20 mL/kg and density of 1.1516 g/mL.
Mortality:
No additional information provided.
Clinical signs:
No additional information provided.
Body weight:
No additional information provided.
Gross pathology:
No additional information provided.
Other findings:
Results were reported only as the LD50 > 20 mL/kg.

Dose was calculated to be 23,032 mg/kg from the reported dose of 20 mL/kg and density of 1.1516 g/mL.

A group of 4 rabbits survived the dose applied undiluted. The dose was the maximum amount of fluid that could be retained in contact with the skin beneath the sheeting. There was no indication of skin condition following the exposure.

Any other information on results incl. tables

No additional information provided.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The dermal LD50 in rabbits is >20 ml/kg bw (23,000 mg/kg).
Executive summary:

Groups of 4 rabbits were dermally administered volumes of test material as high as 20 ml/kg bw. The dermal LD50 was >20 ml/kg (equivalent to approximately 23,000 mg/kg).