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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older, non-GLP proprietary study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Non-standard acute dermal toxicity study
GLP compliance:
no
Remarks:
: study pre-dates GLP
Test type:
other: non-standard design
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No further details are reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
The animals were immobilised in an animal holder and their backs clipped free of hair, approximately 10% of each animal's skin surface.

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
One half of the animals were further prepared by making epidermal abrasions every 2 or 3 centimeters over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneus, bu not deep enough to disturb the dermo. The test material was administered dermally on a g/kg basis.
Duration of exposure:
Not reported
Doses:
A dose of 0.25 g/kg bw was administered to 12 rabbits. Two further animals were used in a range-finding study in which doses of 0.5 g/kg bw and 0.25 g/kg were administered.
No. of animals per sex per dose:
12 (main study)
Control animals:
no
Details on study design:
Forteen male rabbits were used in this experiment. One half of the animals were further prepared by making epidermal abrasions every 2 or 3 centimeters over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneus, bu not deep enough to disturb the dermo. The test material was administered dermally on a g/kg basis. A dose of 0.25 g/kg was administered to 12 rabbits. Two further animals were used and doses of 0.5 g/kg and 0.25 g/kg administered.
Statistics:
None available

Results and discussion

Preliminary study:
Not relevant
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 250 - < 500 mg/kg bw
Remarks on result:
other: 1/1 death at 500 mg/kg bw; 0/13 deaths at 250 mg/kg bw
Mortality:
At a dose level of 0.5 g/kg there was one animal death per level. There were no mortalities at 0.25 g/kg.
Clinical signs:
Edema, erthema, necrosis and eschar were observed at both 0.25 g/kg and 0.5 g/kg.
Body weight:
Not measured
Gross pathology:
no autopsies conducted
Other findings:
No other findings

Any other information on results incl. tables

Deaths occurred at 500 mg/kg bw (1/1); no deaths occured at 250 mg/kg bw (0/13). Local effects (oedema, erythema, eschar and necrosis) were observed at the application site in all animals.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 is estimated to be between 250 -500 mg/kg bw, but is considered likely to be closer to 500 mg/kg bw.
Executive summary:

The test material was applied to the shorn dorsal skin of male New Zealand White Rabbits for an unspecified period of time. Dose levels of 250 and 500 mg/kg bw (1/ rabbit) were used in a range-finding study. In the main study, twelve rabbits were used at a dose level of 250 mg/kg bw; the skin was abraded in half of these animals.

The single animal administered 500 mg/kg bw died. Signs of local severe irritation/corrosion were observed in all animals.

The acute dermal LD50 of the test material is estimated to be between 250 -500 mg/kg bw.