Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate

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:

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)

Version / remarks:

adopted May 12, 1981

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate

Cas Number:

84045-65-8

Molecular formula:

C31H21Na3ClN7O10S3

IUPAC Name:

Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Company code: FAT 40'147/E
Batch No.: EN 94'066.32
Appearance: powder
Purity: 83.3 %
Stability of the test Compound: until October 1988
pH-value: 7.9 (1 g/L water)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Number and sex of animals used: 3 females
- Initial age: 12 - 14 weeks
- Initial body weight range: 2020-2410 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:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

- Application of the Substance:
A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water
moistened before application. Exposure duration was 4 hours.

- Study evaluation:
- Scoring of symptoms and local reactions: 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.
- Mode of calculation: The index of primary cutaneous irritation was calculated as follows:
- the scores obtained for erythema and oedema at 1 hour, 24, 48 and 72 hours after removal of the patch, on the 3 rabbits examined, are summed up
- the sums of total oedema and erythema were divided by 12, when all the animals survived.
- the score obtained is defined as the "index of primary cutaneous irritation".
- Symptoms: daily (a.m. and p.m. on working days, 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.

Interpretation of the primary-irritation index:
< 0.5 : non irritant
0.6 - 3.0 : slightly irritant
3.1 - 5.0 : irritant
5.1 - 8.0 : severely irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Max. score:

4

Remarks on result:

other: Due to intensive staining by the test substance a scoring of the erythema values at 24 hours was not possible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

other: INDEX of skin irritation

Basis:

mean

Time point:

other: 1/24/48/72 h

Score:

0.17

Max. score:

8

Irritant / corrosive response data:

Due to intensive red staining by the test substance a scoring of the erythema values was not possible.

The dermal irritation was evaluated after the score for oedema formation only. The animals had recovered at the end of the observation period of 7 days.

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 40147/E can be considered as not a skin irritant.

Executive summary:

The skin irritation potential of the test substance was evaluated according to OECD Guideline 404. The test was performed on 3 female adult New Zealand White rabbits between the age of 12 - 14 weeks and weighing 2.020 to 2.410 kgs. Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm,- by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). Exposure duration was 4 hours. The skin reaction was appraised after 1, 24, 48, 72 hours and 7 days upon removal of the dressings. The score obtained is defined as the "index of primary cutaneous irritation". Due to intensive red staining by the test substance a scoring of the erythema values was not possible. The dermal irritation was evaluated after the score for oedema formation only. The animals had recovered at the end of the observation period of 7 days. Index of skin irritation was calculated to be 2.33. However, the scores for erythema and edema do not meet the classification criteria proposed by CLP (Regulation 1272/2008). Hence, the substance FAT 40147/E can be considered as not a skin irritant.