Registration Dossier

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other: GLP compliant guideline study, available as unpublished report, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 a significant scratching behaviour was observed on study day 5. The 2 animals, which showed erythema until day 14 also exhibited incrustations from day 6 to day 14. No edema was noted.
Body weight:
The mean body weight increased within the normal range.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Applicant's summary and conclusion