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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 January 1990 - 02 February 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: GLP, The United Kingdom Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, 1989
Qualifier:
according to guideline
Guideline:
other: U.S. FDA, Title 21 Code of Federal Regulations Part 58, Federal Register, 22 December 1978 and subsequent Amendments
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agenct, (FIFRA) Title 40 Code of Federal Regulations Part 160, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency, (TSCA) Title 40 Code of Federal Regulations Part 792, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Health and Welfare Notification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amendment Notification No. Yakuhatsu 870, Pharmaceutical Affairs Bureau, 5 October 1988
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notification No. 3850, Agricultural Production Bureau, 10 August 1984
Qualifier:
according to guideline
Guideline:
other: Japan Ministry of International Trade and Industry, Directive 31 March 1984
Qualifier:
according to guideline
Guideline:
other: OECD ISBN 92-64-12367-9, Paris 1982
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-isopropylacrylamide
EC Number:
218-638-5
EC Name:
N-isopropylacrylamide
Cas Number:
2210-25-5
Molecular formula:
C6H11NO
IUPAC Name:
N-isopropylacrylamide
Test material form:
solid: particulate/powder
Details on test material:
Storage: 4 °C in the dark
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11 to 14 weeks
- Weight at study initiation: 2.6 to 3.3 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: were acclimated (not specified how)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 19 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5g amount of isopropyl acrylamide moistured with 0.5 ml distilled water
Duration of treatment / exposure:
24 hours
Observation period:
72 hours after application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm
- Type of wrap if used: ''Elastoplast'' elastic adhesive dressing backed with ''Sleek'' plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped to remove any residual test substance
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
24h and 72 h

SCORING SYSTEM:
Erythema and eschar formation:
- no erythema 0
- very slight erythema 1
- well-defined erythema 2
- moderate to severe erythema 3
- severe erythema to slight eschar formation 4

Oedema formation:
- no oedema 0
- very slight oedema 1
- slight oedema 2
- moderate oedema 3
- severe oedema 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0.7
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The study was conducted according USA regulations and does not include a 48 hour timepoint

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.
Executive summary:

Based on the CLP application criteria guidance document the substance is not classified for Skin Irritation.