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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is rated a "2" because it applied appropriate testing methods; however, the study predates GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-78-44

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bunnyville Farms, Littlestown, Pennsylvania
- Housing: indivial in metal cages
- Diet: Rabbit ration (Purina Rabbit Chow Checkers) ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Duration of exposure:
24 hours
Doses:
3160 mg/kg bw
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rabbits were observed daily for mortality, and signs of toxic and pharmacologic effects. All rabbits were weighed initially, and at termination (Day14).
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
All 4 rabbits survived the 14 day test period at the 3160 mg/kg dose level.
Clinical signs:
Clinical observation included slight to marked anorexia, and slight to moderate depression in all four rabbits. At termination, all 4 rabbits appeared normal.
Body weight:
All 4 rabbits showed body weight gain. Statistics were not used to determine significance of body weight gain.
Gross pathology:
Gross pathology finding noted in teh animals sacrificed on day 14 included dark red lungs in 3 rabbits and white, raised areas on all lobes of the lungs in the 4th rabbit.
Other findings:
Slight to well-defined erythema was noted in two rabbits at 24 hours. Very slight erythema was noted in these two rabbits at day 3. The remaining two rabbits exhibited very slight erythema at 24 hours. Erythema in these rabbits reversed itself by day 3. No edema was noted in any of the rabbits treated.

Applicant's summary and conclusion

Conclusions:
The LD50 > 3,160 mg/kg bw/day.