Formamide, N-[(2-bromo-5-hydroxy-4-methoxyphenyl)methyl]-N-[2-(4-hydroxyphenyl)ethyl]-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-11-22 to 2005-11-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion); limited information on test material and test system

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.

Test material

Test material information

Constituent 1

Reference substance name:

N-[(2-bromo-5-hydroxy-4-methoxyphenyl)methyl]-N-[2-(4-hydroxyphenyl)ethyl]formamide

Cas Number:

122584-18-3

Molecular formula:

C17H18BrNO4

IUPAC Name:

N-[(2-bromo-5-hydroxy-4-methoxyphenyl)methyl]-N-[2-(4-hydroxyphenyl)ethyl]formamide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): JNJ-28645409-AAA (T002078)
- Physical state: solid (powder)
- Appearance: White, brown grey powder

Specific details on test material used for the study:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Remarks:

intact skin

Vehicle:

not specified

Controls:

other: Untreated skin areas were used as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

three

Details on study design:

TEST SITE: no data

REMOVAL OF TEST SUBSTANCE: no data

OBSERVATION TIM POINTS:
- Skin reactions were recorded at 1, 24, 48 and 72 hours after administration

SCORING SYSTEM:
- Primary Irritation Index, scoring based on observations of Erythema/Eschar formation and Oedema formation. [scoring index: 0= non-irritant, >0-2= mild irritant, >2-5= moderate irritant, >5-8= severe irritant]

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hour readings

Score:

0.5

Max. score:

8

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animals number 19, 21, 22

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

animals number 19, 21, 22

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable - score 0

Irritant / corrosive response data:

- Very slight erythema was noted at two treated skin sites one hour after patch removal and at all treated skin sites at the 24-hour observation. All treated skin sites appeared normal at the 48-hour observation.

Any other information on results incl. tables

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		19 Male	21 Male	22 Male
Erythema/Eschar Formation	1 Hour	0	1	1	(2)
	24 Hour	1	1	1	3
	48 Hour	0	0	0	(0)
	72 Hour	0	0	0	0
Oedema Formation	1 Hour	0	0	0	(0)
	24 Hour	0	0	0	0
	48 Hour	0	0	0	(0)
	72 Hour	0	0	0	0
Sum of 24 and 72 Hour Readings					3
Primary Irritation Index (S/6) and Classification					3/6=0.5
					Mild Irritant

( ) = Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the Primary Irritation Index (PII) was 0.5, indicating that the test substance is a mild irritant. Based on the mean scores for erythema and edema at 24, 48 and 72 hours of the 3 animals and the criteria of the CLP Regulation, the substance is considered as non irritant to the skin.