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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.