sodium hydrogen [5-(diethylamino)-2-[(2-hydroxy-4-nitrophenyl)azo]phenolato(2-)][5-hydroxy-6-[(2-hydroxy-4-nitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, chromate(2-)

Endpoint summary

Description of key information

Eye irritation: Not irritating

Skin irritation: Not irritating

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:

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

Adequacy of study:

key study

Study period:

From May 31 to June 03, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

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-88397 Biberach.
- Weight at study initiation: between 2190 to 2310 g.
- Housing: individually in metal cages.
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum.
- Water: ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: A gauze patch (approx. 12-16 cm2) bearing 0.5 g of test substance.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze patch

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

other: Not classified according to the CLP Regulation

Conclusions:

Not irritating.

Executive summary:

Method:

The Skin irritation was determined in an irritation test on rabbits according to the OECD Guideline 404 and the EU Method B.4.

 

Result:

Not irritating

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

supporting study

Study period:

From December 06 to 13, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

not specified

GLP compliance:

no

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.
- Weight at study initiation: 2 - 3 kg.
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: Gauze patches soaked (or loaded) with 0.5 g of the test material.

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm2.
- Type of wrap if used: Gauze patches covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape . The dressings were removed after 24 hours.

Irritation parameter:

erythema score

Basis:

animal: 25, 26, 29

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal: 27

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal: 28

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal: 30

Time point:

24/48/72 h

Score:

ca. 1.66

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal: 25, 28

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

not fully reversible within: 48 hours

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal: 26

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal: 27

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal: 29

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal: 30

Time point:

24/48/72 h

Score:

ca. 1.66

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: intact skin

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritating

Executive summary:

Method:

The skin irritation was determined in an irritation test on rabbits according to an internal method similar to the EPA OPP 81-5 (Acute Dermal Irritation).

Observation:

An animal showed erythema and edema not fully reversible within the 7 days observation period.

Result:

Not irritating

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:

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

Adequacy of study:

key study

Study period:

From June 7 to July 5, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-88397 Biberach.
- Weight at study initiation: between 2040 to 2340 g.
- Housing: housed individually in metal cages.
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland ad libitum.
- Water: ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg was placed into the conjunctival sac of the left eye.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritating

Executive summary:

Method:

The eye irritation was determined in an irritation test on rabbits according to OECD Guideline 405 and EU Method B.5.

Observation:

Under the experimental conditions employed the test substance induced reactions of the iris and conjunctiva when instilled into the conjunctival sac of albino rabbit eyes. These effects are fully reversible within 7 days and the mean value of the readings 24 to 72 hours after instillation are below the threshold of significance.

Result:

Not irritating

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

supporting study

Study period:

From December 06 to 13, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

other: Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study", Federal Register, Vol. 43 No. 163 August 22, 1978

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintiertarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were housed individually in metal cages
- Diet: Rabbit food, NAFAGr No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Vehicle:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g of test substance

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the treated eye was flushed with 10 ml of sterile physiological saline
- Time after start of exposure: 30 sec

Irritation parameter:

cornea opacity score

Remarks:

Opacity

Basis:

animal: 28

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: washed eyes

Irritation parameter:

cornea opacity score

Remarks:

Opacity

Basis:

animal: 29, 30

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No ocular effect observed

Remarks on result:

other: washed eyes

Irritation parameter:

iris score

Basis:

animal: 28, 29, 30

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No ocular effect observed

Remarks on result:

other: washed eyes

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 28

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: washed eyes

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 29

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No ocular effect observed

Remarks on result:

other: washed eyes

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 30

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: washed eyes

Irritation parameter:

chemosis score

Basis:

animal: 28, 30

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: washed eyes

Irritation parameter:

chemosis score

Basis:

animal: 29

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No ocular effect observed

Remarks on result:

other: washed eyes

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritant

Executive summary:

Method:

The eye irritation was determined in an irritation test on rabbits according to the Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study", Federal Register, Vol. 43 No. 163 August 22, 1978.

Result:

Not irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

According to the CLP Regulation (EC n. 1272/2008) a substance shall be classified as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.

Category 2:

- Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

- Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

- In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical eposure in a single animal but less than the criteria above.

The substance is not classified as skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.

 

EYE IRRITATION

According to the CLP Regulation (EC n. 1272/2008), a susbtance shall be classified as Irritating to eyes (Category 2) when applied to the eye of an animal, produces:

- At least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

The test substance does not meet the requirements to be classified in Category 2, therefore it is not classified.