5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium trichlorozincate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

from November 15 to 22, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Source study has reliablity 1. Details on the read across are attached in section 13.

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:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.3, 2.7, 3.3 kg
- Housing: one rabbit per cage (Drahtkäfige Typ III - hoch)
- Pellet: Holzgranulat Typ S 8/15 (Firma Sniff, Soest)
- Diet: ca. 100 - 120 g per animal per day of Sniff K 4 (Sniff Spezialdiäten GmbH, Soest/Westfallen)
- Water: ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: ca. 50 %
- Air changes: ca. 10 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours (ca. 27 Watt/m2)

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): 500 µl
- pH: 0.5

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Application of the test item on Hansamed - Wundpflaster "Hypoallergen" Beisedorf n. 2342
- Coverage: Fixomull - Stretch klebevlies, Beisedorf n. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize grade

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: no skin reaction

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: no skin reaction

Any other information on results incl. tables

animal n.	weight	sex	1hour		24 hours		48 hours		72 hours		7 days		14 days
			E	O	E	O	E	O	E	O	E	O	E	O
T54	3.3 kg	female	0	0	0	0	0	0	0	0	0	0	0	0
T41	2.7 kg	female	0	0	0	0	0	0	0	0	0	0	0	0
S13	3.3 kg	female	0	0	0	0	0	0	0	0	0	0	0	0

 

E = erythema,  O = oedema

Applicant's summary and conclusion

Interpretation of results:

other: not irritant according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not irritant.

Executive summary:

Method

The substance was tested according to OECD guideline 404, using 3 females of albino rabbit.

Results

No skin effects were noted during the 7 days of observation after application.