Reaction mass of Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-7-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate and Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-6-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-7-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate and Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-6-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate

EC Number:

916-837-8

Molecular formula:

C29H16Na4ClN9O12S4

IUPAC Name:

Reaction mass of Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-7-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate and Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-6-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

None

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species and strain: The albino rabbit has been selected as being a recognized species for the conduct of acute dermal irritation studies. New Zealand White Rabbits checked for normal dermal conditions.
Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf.
Number and sex of animals used: 3 females
Initial age: 12 - 14 weeks
Initial body weight range: 1900-2100 g
Individual identification: numbered ear tags. The cages were marked with sex, animal No., GU-Project No. and the company code of the test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20+3 °C, relative humidity 30-70 %; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were sacrificed by intravenous injection of hypnotic T61 (Hoechst).

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: The back of the experimental animals was shaven with an electric clippeing (an area t 6 sq. cm).

Vehicle:

water

Controls:

yes

Amount / concentration applied:

0.5 g of the test to the skin

Duration of treatment / exposure:

Exposure duration was 4 hours.

Observation period:

1, 24, 48, 72 hours observation period.

Number of animals:

3 Females

Details on study design:

Application of the Substance:

Not less than 24 hour the back of the experimental animals was shaven with an electric clipper. 0.5 g of the test material added to the skin.
The substance was moistened before application
Exposure duration was 4 hours.
Symptoms: daily a.m. and p.m., once daily on weekends and holidays.

Body weight: at beginning of acclimatization and end of test
Mortality: daily a.m. and p.m., once daily on weekends and holidays

After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following observation period.
The score obtained is defined as the "index of primary cutaneous irritation".

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

not specified

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

not specified

Irritant / corrosive response data:

None

Other effects:

The animals showed a normal body weight development.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40069/A is considered to be a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine potential of FAT 40032/C to cause skin irritation in rabbits according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). 0.5 g of the test compound was applied and the exposure duration was 4 hours. No irritation reactions were seen. The animals showed a normal body weight development. Hence based on the findings of the study, it can be concluded, that FAT 40032/C is neither irritating nor corrosive when applied to the rabbit skin.