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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan/Feb 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: US Federal Register 38, No. 187, § 1500.41
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
EC Number:
241-481-9
EC Name:
2,2'-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bisethanol
Cas Number:
17464-91-4
Molecular formula:
C16H15BrCl2N4O4
IUPAC Name:
2-({4-[(E)-2-(2-bromo-6-chloro-4-nitrophenyl)diazen-1-yl]-3-chlorophenyl}(2-hydroxyethyl)amino)ethan-1-ol
Test material form:
liquid
Details on test material:
Disperse Brown 4

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Housing: One animal per cage, cages: stainless steel with wire inlays, base area 40 x 51 cm
- Diet (e.g. ad libitum): ad libitum, ca. 130 g per animal per day, diet: Ovator Solikanin 4 MM, Muskator Werke, Düsseldorf, Germany
- Water (e.g. ad libitum): ad libitum, 250 mL per animal per day, Monday-Friday: VE-water, Saturday-Sunday: tap water
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm; upper third of the back or flank

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30-60 min after exposure period and 24, 48 and 8 days after start of application

SCORING SYSTEM:
- Method of calculation: Scoring according to the Method of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation observed


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was not found to be irritating on rabbit skin. The substance is not classifiable according to CLP criteria.