N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

dermal absorption in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read across is based on the same physico-chemical properties, a close structural similarity and the same mechanism of action during use processes.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Source: Disperse Blue 79:1
Substance Name: 2,2’-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
EC Number: 222-813-1
CAS Number: 3618-72-2

- Target: Disperse Blue 291:1 Br

3. ANALOGUE APPROACH JUSTIFICATION
see attachment section 13

4. DATA MATRIX
see attachment section 13

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

The cutaneous penetration kinetics of structural analogue 03 in human abdominal skin samples were measured using in vitro techniques for a 6 h period along with parallel testing of other substances. The amount of test substance penetrating skin samples and collected in the effluent were measured by liquid scintillation spectrometry or high-performance liquid chromatography (HPLC).

Radiolabelling:

yes

Total recovery:

No information available

Skin penetration of the test substance, applied to human abdominal skin, could not be detected by HPLC above the minimum detection limit of 1 µg/mL. The results thus indicate that human dermal exposure to the test substance would probably not result in a significant absorbed dose.

Conclusions:

Skin penetration of the test substance, applied to human abdominal skin, could not be detected by HPLC above the minimum detection limit of 1 µg/mL. The results thus indicate that human dermal exposure to the test substance would probably not result in a significant absorbed dose.

Executive summary:

A study was conducted to determine the in vitro dermal penetration of the test substance in human abdominal cells. Skin penetration of the structural analogue 03, applied to human abdominal skin, could not be detected by HPLC above the minimum detection limit of 1 µg/mL. The results thus indicate that human dermal exposure to the test substance would probably not result in a significant absorbed dose (Sun, 1995).