4-nitrophenyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: MatTek Protocol for: INVITRO EpiDermTM SKIN IRRITATION TEST For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm, Model EPI- 200-SIT, Rev. 26/3/2012,1-37

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, 4-nitrophenyl ester

IUPAC Name:

Acetic acid, 4-nitrophenyl ester

Constituent 2

Reference substance name:

4-nitrophenyl acetate

EC Number:

212-593-5

EC Name:

4-nitrophenyl acetate

Cas Number:

830-03-5

Molecular formula:

C8H7NO4

IUPAC Name:

4-nitrophenyl acetate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): 4-Nitrophenyl Acetate

- Physical state: solid
- Analytical purity: 95 % w/w
- Impurities (identity and concentrations):
Phenol <5.0 % (w/w)
4-nitrophenol <5.0 % (w/w)
Acetic acid <1.0 % (w/w)
Water <5.0 % (w/w)

- Lot/batch No.: 201409
- Expiration date of the lot/batch: unlisted

- Storage condition of test material: During the study the test substance was stored in closed
container in the dark at laboratory temperature.

Test animals

Species:

other: reconstructed human epidermal model EpiDerm™ (EPI-200 ver. 2.0, MatTek, Ashland, USA); Lot No. 21646, kit A

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

not specified

Results and discussion

Any other information on results incl. tables

Table 1: OD570 values obtained at the MTT test, their means, standard deviations and relative viabilities (%)

	Treatment	OD570	Mean	SD	Relative viability
	1	2	3	(% NC)
NC	PBS	1.874	1.976	2.015	1.955	0.059	100.0
	viability (% NC)	95.86	101.07	103.07	100.00	3.041
C1	65/15	1.279	1.850	1.818	1.649	0.262	84.3
	viability (% NC)	65.42	94.63	92.99	84.35	13.399
PC	5% SDS	0.049	0.045	0.045	0.046	0.002	2.4
	viability (% NC)	2.51	2.30	2.30	2.37	0.096

NC = negative control

PC = positive control

C1 = test substance

mean = arithmetic mean

SD = standard deviation calculated from individual % tissue viabilities

viability (%) = viability of single tissues compared with negative control, mean NC viability is defined as 100

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the above-described experimental design, average viability of tissues treated by the test substance was 84.3 % of negative control average value, i.e. viability was > 50 %.

Executive summary:

The effect of the test substance was negative in EpiDermTM model.

According to the classification criteria given in chapter 3.9. of this report, the test substance is considered to have no category in regard to skin irritation.