2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1989-08-29 to 1989-09-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium chloride

EC Number:

248-053-0

EC Name:

2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium chloride

Cas Number:

26850-47-5

Molecular formula:

C19H23ClN4O2S

IUPAC Name:

2-[(E)-{4-[Ethyl(2-hydroxyethyl)amino]phenyl}diazenyl]-6-methoxy-3-methyl-1,3-benzothiazol-3-ium chloride

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Dr. K. Thomae GmbH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Acclimatisation period: at least 5 days
- Weight at study initiation: 2160 - 2990 g
- Housing: one animal per cage at 20 ± 3 °C, 30-70% relative humidity and 12 hours light cycle day
- Diet: ad libitum, Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum

Test system

Type of coverage:

semiocclusive

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 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: 12-16 cm²
- % coverage: full
- Type of wrap if used: covered with aluminum foil (approx. 36 cm²) and held in place with adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- Method of calculation: Draize (see table 1 in box "any other information on materials and methods incl. tables"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

due to colouration of the skin by the test item the evaluation for the first 24 h was difficult

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The indiviual scores are presented in Table 2 (see box "Any other information on results incl. tables"). No erythema scores according to Draize were awarded due to colouration of the skin by the test substance for the first 24 hours. From 48 hours to 72 hours no reactions were observed.

Other effects:

No effects on body weight gain were seen.

Any other information on results incl. tables

Table 2: Individual skin reaction score

	Erythema			Edema
Animal number	660/F CF/TF	954/F CF/TF	976/F CF/TF	660/F CF/TF	954/F CF/TF	976/F CF/TF
After 1 h	0/*	0/*	0/*	0/0	0/0	0/0
After 24 h	0/*	0/*	0/*	0/0	0/0	0/0
After 48 h	0/0	0/0	0/0	0/0	0/0	0/0
After 72 h	0/0	0/0	0/0	0/0	0/0	0/0
Mean 24-72 h	0/0#	0/0#	0/0#	0/0	0/0	0/0

CF= control flank             

TF = test flank

M = male                          

F = female

* = dark blue staining   

# = mean 48 - 72 hours 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, in an acute dermal irritation/corrosion study conducted according to OECD 404 the test item is considered to be non-irritating to the skin.

Executive summary:

In a primary dermal irritation study (OECD 404), three female New Zealand White rabbits were dermally exposed to 0.5 g of the test item on a moistened gauze patch to the shaved flank for 4 hours to an area of 12 x 16 cm² under semi-occlusive conditions. Animals were then observed for 72 hours. Irritation was scored by the method of Draize. In this study, the test item is not a dermal irritant.