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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline available

Principles of method if other than guideline:

The study report contains the limited information on the test conditions because the study has been performed in 1976. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS - Sex: male

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

0.5 g

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

0

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: later observation

Score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

non-irritating

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

no

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS - Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf - Age at study initiation: 12 - 14 weeks - Weight at study initiation: 2300-2600 g - Housing: Animals were housed individually in metal cages - Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum - Water (e.g. ad libitum): water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20±3° C - Humidity (%): 30-70 % - Air changes (per hr): 12 hours light/day - Photoperiod (hrs dark / hrs light): approximately 15 air changes/h.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

A gauze patch bearing 0.5 ml of the test substance was applied to the skin

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3 males

Details on study design:

None

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings .

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40170/B is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the acute irritation, provoked by the compound, FAT 40170, on the skin of the rabbits according to the OECD guidelines for testing of chemicals: Acute dermal Irritation/Corrosion No. 404, adopted May 12, 1981 by the OECD Council. 6 rabbits, Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. 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. 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. There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.Therefore FAT 40170/A is to be considered as a non-irritant to the skin of rabbits.

 

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

no

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS - Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf - Age at study initiation: 12 - 14 weeks - Weight at study initiation: 2030-2080 g - Housing: Animals were housed individually in metal cages. - Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum - Water (e.g. ad libitum): water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20±3° C - Humidity (%): 30-70 %; - Air changes (per hr): 12 hours light/day - Photoperiod (hrs dark / hrs light): 15 air changes/h.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 g of the test substance was applied to the skin

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3 males

Details on study design:

None

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings .

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40170/B is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the acute irritation, provoked by the compound, FAT 40170, on the skin of the rabbits according to the OECD guidelines for testing of chemicals: Acute dermal Irritation/Corrosion No. 404, adopted May 12, 1981 by the OECD Council.

Six rabbits, Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. 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. 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. There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.Therefore FAT 40170/B is to be considered as a non-irritant to the skin of rabbits.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline available

Principles of method if other than guideline:

The study report contains the limited information on the test conditions because the study has been performed in 1991. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 g

Irritation parameter:

cornea opacity score

Basis:

mean

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Score:

> 0 - < 1

Max. score:

3

Reversibility:

not specified

Interpretation of results:

GHS criteria not met

Conclusions:

non-irritating

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1963

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

no

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf- Age at study initiation: 12 - 14 weeks- Weight at study initiation: 2130-2560 g- Housing: Animals were housed individually in metal cages.- Diet (e.g. ad libitum): rabbit food ad libitum- Water (e.g. ad libitum): water ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 20±3° C- Humidity (%): 30-70 %- Air changes (per hr): approximately 15 air changes/h.- Photoperiod (hrs dark / hrs light): 12 hours light/day

Vehicle:

unchanged (no vehicle)

Controls:

yes

not specified

Amount / concentration applied:

0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal

Duration of treatment / exposure:

The lids were then held together for about one second in order to prevent loss of the test material.

Duration of post- treatment incubation (in vitro):

1, 24, 48, 72 hours

Number of animals or in vitro replicates:

3 animals

Details on study design:

None

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

None

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40170 is considered to be a non-irritant to the eyes.

Executive summary:

In a study performed to determine the eye irritation potential of FAT 40170, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1, 24, 48 and 72 hours. The body weight in 1 animal was decreased during the test period. No other reactions to treatment were recorded during the whole observation period. Based on these findings, FAT 40170 is considered to be a non-irritant to the eyes.

Reference 3

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1963

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

no

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf- Age at study initiation: 12 - 14 weeks- Weight at study initiation: 2500 - 2700 g- Housing: Animals were housed individually in metal cages.- Diet (e.g. ad libitum): rabbit food ad libitum- Water (e.g. ad libitum): water ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 20±3° C- Humidity (%): 30-70 %- Air changes (per hr): approximately 15 air changes/h.- Photoperiod (hrs dark / hrs light): 12 hours light/day

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml of the test article was placed into the conjunctival sac of the right eye of each animal.

Duration of treatment / exposure:

The lids were then held together for about one second in order to prevent loss of the test material.

Duration of post- treatment incubation (in vitro):

1, 24, 48, 72 hours

Number of animals or in vitro replicates:

3 animals

Details on study design:

None

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

None

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40170/A is considered to be a non-irritant to the eyes.

Executive summary:

In a study performed to determine the eye irritation potential of FAT 40170, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1, 24, 48 and 72 hours. The body weight development was not affected by the application of the test article. No other reactions to treatment were recorded during the whole observation period. Based on these findings, FAT 40170/A is considered to be non-irritant to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No adverse effect was found on skin or eye. Reactive Orange 13 does not meet the criteria for classification according to Regulation (EC) No. 1272/2008.