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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, some restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Five male and five female rabbits were used for a single dermal dosage level of 2.0 g/kg bw and held for an observation period of 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Sample number: 41105731

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver PA
- Age at study initiation: 14 weeks
- Weight at study initiation: 2497 - 2891 g
- Housing: screen-bottom cages, individually
- Diet: ad libitum, Teklad Laboratory Rabbit diet
- Water: ad libitum
- Acclimation period: at least 7 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: test material is moistened with 0.9% saline
Details on dermal exposure:
TEST SITE
- Area of exposure: animals' shaved back
- % coverage: shaved area made up approximately 20% of the total body surface
- Type of wrap if used: 4x4-inch gauze patch secured with paper tape and overwrapped with Saran Wrap and Elastoplast tape.
- Just before the test material was applied, longitudinal epidermal abrasions (deep enough to penetrate the stratum corneum, not deep enough to penetrate to the dermal layer and cause bleeding) were made on the exposed back of two male and three female animals.

REMOVAL OF TEST SUBSTANCE
- Backs were wiped clean with wet disposable paper towels.
- Time after start of exposure: 24 hrs
Duration of exposure:
single dose for 24 hrs
Doses:
2.0 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations (dermal irritation, clinical signs and mortality): daily; weighing: just prior to test material application and on day 7 and 14
- Necropsy of survivors performed: no
Statistics:
not reported

Results and discussion

Preliminary study:
not performed
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 other: g/kg bw
Mortality:
no mortality
Clinical signs:
no clinical signs are reported
Body weight:
no differences in body weight observed between dosage levels
Gross pathology:
not reported

Applicant's summary and conclusion