2-pyrrolidone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-05-13 to 2003-05-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to OECD 404; US EPA , OPPTS 870.2500; EU Method B.4 and JMAFF, Japanese test guideline without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

The testing facilty indicated that the protocol was followed without deviation.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

The testing facilty indicated that the protocol was followed without deviation.

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Remarks:

The testing facilty indicated that the protocol was followed without deviation.

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF , Japanese guideline

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-pyrrolidone

EC Number:

210-483-1

EC Name:

2-pyrrolidone

Cas Number:

616-45-5

Molecular formula:

C4H7NO

IUPAC Name:

pyrrolidin-2-one

Test material form:

solid

Details on test material:

- Name of test material: HC1161
- Substance type: pure active substance
- Physical state: colourless-white solid
- Analytical purity: not indicate by sponsor, treated as 100 % pure
- Expiration date of the lot/batch: 2003-07-31
- Stability under test conditions: stable under storage condition
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors
- Diet: approx. 100 g standard laboratory rabbit diet per day, pressed hay twice a week
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 22.5
- Humidity (%): 38 - 7
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours artificial fluorescent light per day

IN-LIFE DATES: From: 2003-05-13 To:2003-05-30

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: not treated skin of treated animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

4hr

Observation period:

at 1, 24 48, 72 hrs

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal area free of fur (150 square centimeters)
- % coverage: no data
- Type of wrap if used: metalline patch of 2x3 cm

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4hr

SCORING SYSTEM:
Eyrthema and eschar formation:
0 No erythem
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to sever erythema
4 Severe erythema (beet redness)
Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (=4) is given.

Oedema formation:
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (raised approximately 1 millimeter)
4 Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

312 (sentinel)

Time point:

other: 1 hr

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

312 (sentinel)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

338

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: After 1 hour the same observations were made.

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

348

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: After 1 hour the same observations were made.

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

312 (sentinel)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: After 1 hour the same observations were made.

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

338

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: After 1 hour the same observations were made.

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

348

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: After 1 hour the same observations were made.

Irritant / corrosive response data:

-Irritation: at 4 h exposure to 0.5 g of HC1161 resulted in very slight erythema in treated skin-area of 1/4 rabbit, which had resolved within 24 hours after exposure (see Remarks on results").
-Corrosion: There was no evidence of a corrosive effect on the skin.

Other effects:

-Colouration: No staining of the treated skin by the test substance was observed.
-Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Any other information on results incl. tables

Table: Individual Skin Irritation Scores
Animal #	312 (sentinel)			338			348
Time after exposure	Erythema	Oedema	comments	Erythema	Oedema	comments	Erythema	Oedema	comments
1 hour	1	0	-	0	0	-	0	0	-
24 hours	0	0	-	0	0	-	0	0	-
48 hours	0	0	-	0	0	-	0	0	-
72 hours	0	0	-	0	0	-	0	0	-

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

1 rabbit reversible (within 24 h) slight irritation (after 4 h exposure). Criteria used for interpretation of results: other: EU GHS

Conclusions:

According to EC criteria for classification and labelling the HC1161 (2-pyrrolidone) does not have to be classified and has no obligatory labelling requirement for skin irritation.

Executive summary:

The study was conducted in compliance with the OECD Guideline 404 and GLP. The objective of this primary skin irritation study was to assess the irritation potential of a single dose of the test substance administered to the intact skin of rabbits. Three rabbits were exposed to 0.5 gramm of HC1161 (2 -pyrrolidone), applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observation were made 1, 24, 48 and 72 hours after exposure.

No skin irritation was observed after exposure. The test material is not irriating to the skin.