N-(n-octyl)-2-pyrrolidinone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(n-octyl)-2-pyrrolidinone

EC Number:

403-700-8

EC Name:

N-(n-octyl)-2-pyrrolidinone

Cas Number:

2687-94-7

Molecular formula:

C12 H23 N O

IUPAC Name:

1-octylpyrrolidin-2-one

Details on test material:

- Name of test material (as cited in study report): N-(N-Octyl)Pyrrolidone; Substance No. 91/453
- Physical state: colorless liquid
- Analytical purity: 99.3 %
- Lot/batch No.: 103/90
- Storage condition of test material: refrigerator

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. Thomae GmbH, D-W7950 Biberach
- Age at study initiation: young adults
- Weight at study initiation: 150-300 g
- Fasting period before study: 16 hrs
- Housing: individual
- Diet: Kliba laboratory diet, Klingenthalermühle, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk; about 50 cm²
- % coverage: 25-17 (calculated with a body surface area of 300-400 cm² depending on a body weight of 200-300 g as specified above)
- Type of wrap if used: semiocclusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.43, 2.17, 4.34 ml/kg bw, respectively
- Concentration (if solution):
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

400, 2000, 4000 mg/kg

No. of animals per sex per dose:

5 males and females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily on working days, recordings of signs and symptoms several times/day; once on weekends
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Mortality:

In the highest dosing group 2 female animals died after one day and another female on day 2 after substance application.

Clinical signs:

other: Signs of toxicity noted in the 4000 mg/kg group comprised poor general state, dyspnoea, apathy, abdominal or lateral position, atonia, paresis, narcotic-like state, absent corneal and pain reflex, red-coloured urine and red-smeared fur in the anogenita

Gross pathology:

Animals that died (females)
4000 mg/kg (3 females)
general congestion
Liver intensified grayish-brown lobule liver pattern, partly confluent
Kidneys: black-brown tinge urine, bloody coloured

Histopathology:
4000 mg/kg (1 female):
Liver: increased lipid storage in the lobular periphery
Kidneys: acute necrosis of tubular cells in the cortex, focal fatty degeneration of tubular cells, diffuse
Urinary bladder: blood filled

Sacrificed animals: no pathologic findings noted

Applicant's summary and conclusion

Interpretation of results:

not classified