1-(2-hydroxyethyl)pyrrolidin-2-one

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-hydroxyethyl)pyrrolidin-2-one

EC Number:

222-359-4

EC Name:

1-(2-hydroxyethyl)pyrrolidin-2-one

Cas Number:

3445-11-2

Molecular formula:

C6H11NO2

IUPAC Name:

1-(2-hydroxyethyl)pyrrolidin-2-one

Details on test material:

- Name of test item: N-(2-Hydroxyethyl)-2-pyrrolidon
- Test item No.: 04/0443-2
- Batch identification: O 2909
- Purity: 99.7 area-% determined by GC-analysis
- Homogeneity: The test item was homogeneous by visual inspection.
- Storage stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage conditions: Room temperature
- Physical state/ color: Liquid / colorless to yellow, clear

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males, 8 weeks; females, 12 weeks
- Weight at study initiation: males, 233 g; females, 211 g
- Fasting period before study: no
- Housing: single housing in Makrolon cage, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): fully air-conditioned room
- 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: 40 cm2
- % coverage: 10
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze and stretch bandage)

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.75 mL/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/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: body weights were determined before administration (day 0), weekly thereafter and on the last day of observation; clinical signs were recorded several times on the day of administration and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: skin irritation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs observed. Local effects were not observed in males. In females, slight erythema (grade 1) was observed in all animals starting on study day 1 until day 2, 5 or 6 (1 animal each) or until day 14 (2 animals). In 4 out of 5 females

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met