Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 09 to 23 April 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study summary. No guideline. Only mortality performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Modification of procedures as described by J. H. Draize
Deviations:
no
Principles of method if other than guideline:
Six (3M: 3F) New Zealand White rabbits, each received a single dermal application of the test substance at a dose level of 2 g/kg bw. The
test sites were occluded for 24 hours, at which time the occlusive wrap and any remaining test substance were removed.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: Not specified
Batch No.: Not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Camm Research in Wayne, NJ.
- Age at study initiation: Approx. 3-4 months
- Weight at study initiation: Approx. 2.3 kg
- Fasting period before study:
- Housing: Housed in galvanized or stainless steel cages.
- Diet (e.g. ad libitum): Consisted of Pro-Pet Big Red Rabbit Feed.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65 to 75 F.
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.

IN-LIFE DATES: From: 09 April 1987 To: 23 April 1987

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used: An impermeable plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed off the skin with water and paper towels.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw
- Concentration (if solution):
- Constant volume or concentration used:
- For solids, paste formed:

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
2 g/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
not required
Details on study design:
Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours post-dosage. Observations were made at least once daily thereafter for a total of 14 days.
Animals sacrificed at the end of the 14 day observation period, with an injection of T-61 euthanasia solution. Those, as well as non-survivors, were weighed and subjected to complete gross necropsy, with all findings recorded.
Statistics:
None stated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The mortality was 17% (one female animal died on Day 5, no deaths among males).
Clinical signs:
Clinical signs were normal for all animals except for the animal found dead on Day 5.
Body weight:
None stated
Gross pathology:
None stated

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not toxic dermally to rabbits under conditions of this test.