N-(n-dodecyl)pyrrolidinone

Acute Toxicity: dermal

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.