N-[3-(diethylamino)phenyl]acetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment report

Data source

Reference

Reference Type:

review article or handbook

Title:

SIDS INITIAL ASSESSMENT PROFILE-MALEIC ANHYDRIDE AND MALEIC ACID

Author:

OECD SIDS

Year:

2004

Bibliographic source:

OECD SIDS ;SIDS Initial Assessment Report For SIAM 18 Paris, France, 20-23 April 2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin irritation study of Maleic anhydride (CAS no: 108-31-6) was conducted on six New Zealand White rabbits to observe its irritation efficacy.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,5dihydrofuran2,5dione

Cas Number:

108-31-6

Molecular formula:

C4H2O3

IUPAC Name:

2,5dihydrofuran2,5dione

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Maleic anhydride
- Molecular formula: C4H2O3
- Molecular weight: 98.0568 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: C1(OC(=O)C=C1)=O
-InChI: 1S/C4H2O3/c5-3-1-2-4(6)7-3/h1-2H

Specific details on test material used for the study:

- Name of test material (as cited in study report): Maleic anhydride
- Molecular formula: C4H2O3
- Molecular weight: 98.0568 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: C1(OC(=O)C=C1)=O
-InChI: 1S/C4H2O3/c5-3-1-2-4(6)7-3/h1-2H

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No Data Available

Test system

Type of coverage:

not specified

Preparation of test site:

other: Intact skin

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

500mg (0.5g)

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

6

Details on study design:

- Area of exposure: backs of six rabbits
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Severe skin irritation was present in both treated areas of most rabbits for the entire 7-day observation period. Eschar formation with epidermal regeneration was present in all of the sections.

Any other information on results incl. tables

THE DRAIZE SKINIRRITATION SCORES
Skin reactions	Test Sites	Mean scores (time)
		24 hours	48 hours	2 hours	Day 7
Erythema formation	Site 1	4	4	4	4
	Site 2	3.7	4	4	4
edema formation	Site 1	4	3.8	3.7	3.7
	Site 2	3.7	3.5	3.0	3.0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material Maleic anhydride (CAS no: 108-31-6) was considered to be highly irritating to the skin of New Zealand White rabbits.

Executive summary:

Skin irritation study of Maleic anhydride (CAS no: 108-31-6) was conducted on six New Zealand White rabbits toto assess the irritationefficacy.

 

In this study, 500mg (0.5g) was applied to two intact skin locations on the backs of six rabbits for four hours and skin reactions were observed for 7 days.

 

Severe skin irritation was present in both treated areas of most rabbits for the entire 7-day observation period. Eschar formation with epidermal regeneration was present in all of the sections. At 24 hours, the Draize scores for erythema and edema for site 1 (site 2) were 4.0 (3.7) and 4.0 (3.7), respectively. At 48 hours, the scores for erythema and edema were 4.0 (4.0) and 3.8 (3.5), respectively. At 72 hours, the erythema and edema scores were 4.0 (4.0) and 3.7 (3.0), respectively. At 7 days, the erythema and edema scores were 4.0 (4.0) and 3.7 (3.0), respectively.

 

Sever signs of irritation were observed during 7 days observation period. Hence theMaleic anhydride (CAS no: 108-31-6) was considered to be highly irritating to theNew Zealand Whiterabbit’s skin.