Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Endpoint summary

Description of key information

Skin irritation was determined in vivo in rabbits. No signs of irritation were detected at all time points.
Eye irritation was determined in vivo in rabbit eyes. Only the conjuntivae show transient mild effects. No ocular efffects were detected.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Standard guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Chbb: NZW (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH Postfach 1755 D-88397 Biberach a.d. Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: 2,7-2,92 kg
- Housing: individual in stainless steel cages (size: 120x52x60 em)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 40 -70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 /12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: PEG 400 / 0,9% NaCl in Water (7/3)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): moistened solid

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of exposure with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM:
EVALUATION OF SKIN REACTION
Erythema and eschar formation
No erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight erythema (barely perceptible) . .. . . ........... 1
Well defined erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate to severe erythema ....... ........ .. ........ .. . .. 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) . . . . ..... .. ................. 4
Maximum possible score 4

Edema formation
No edema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight edema (barely perceptible) ................ ... 1
Slight edema (edges of area well defined by
definite raising) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate edema (raised approximately 1 mm) . .. .. .......... 3
Severe edema (raised more than 1 mm and
extending beyond area of exposure) ......... .............. 4
Maximum possible score 4
Maximum cumulative score: 8

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: mean of all observations

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Only one of three animals showed a very slight erythema at 24 and 48 ours after exposure

Other effects:

blacj discoloration of the skin due to the color of the test material (black pigment)

Time	Animal	Sex	Erythema	Edema	Cumulative	Mean
1h	40	M	0	0	0
	41	F	0	0	0
	42	F	0	0	0	0
24 h	40	M	0	0	0
	41	F	0	0	0
	42	F	1	0	1	0,33
48h	40	M	0	0	0
	41	F	0	0	0
	42	F	1	0	1	0,33
72 h	40,41,42	M,F,F	0	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the observation and on the refered classification criteria (EEC Commission Directive 93/21/EEC, April 27,1993) the test material is classified as non-irritant to the skin of rabbits

Executive summary:

The primary skin irritation potential of the test material was investigated by topical application of 0.5 g onto 6 cm² intact dorsal skin of each of three young adult New Zealand rabbits.

The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then divided by the number of figures.

Under the conditions of this experiment, the test item was found to cause a primary irritation score of 0.22 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.22 erythema and grade 0.00 edema. In the area of application, a slightly black staining of the treated skin by coloring of the test article was observed during the whole observation period.

No corrosive effect occurred on the treated skin of any animal at each measuring interval.

According to EEC Commission Directive 93/21/EEC, April 27, 1993, the mean values of the scores for each type of lesion, calculated for each animal separately, are the following:

Animal No.,       Sex                     Mean 24 - 72 Hours

Erythema       Edema

40                     male                     0.00                    0.00

41                     female                  0.00                    0.00

42                     female                 0.67                     0.00

Due to the results described above, the test article is classified as 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

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Standard guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH Postfach 1755; D-88397 Biberach a.d. Riss
- Age at study initiation: 14 weeks
- Weight at study initiation: 2,86 - 3,01 kg
- Housing: Individually in stainless steel cages (size: 120 x 52 x 60 em)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 40-70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye

Duration of treatment / exposure:

single application, no washing

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 0-72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1-72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1-72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1-72 h

Score:

0.78

Reversibility:

fully reversible

Irritant / corrosive response data:

IRRITATION (see Appendix A, pp. 23-25)
SAVINYL BLACK RLSN showed a primary irritation score of: 0.78, when applied to the conjunctival sac of the rabbit eye.
CORROSION
No corrosion of the cornea was observed at any of the reading times.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on these observation and on the refered classification criteria (EEC Commission Directive 93/21/EEC, April 27, 1993) the test article is not irritant to the eye of rabbits.

Executive summary:

The primary irritation potential of the test substance was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits.

The treated eyes were not rinsed after substance application.

Scoring of irritation effects were performed 1, 24, 48 and 72 hours and 7 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. It was found to be 0.78 (max. 13). No staining of the cornea and conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals.

Based on these observation and on the refered classification criteria (EEC Commission Directive 93/21/EEC, April 27, 1993) the test article is not irritant to the eye of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation was determined in vivo in rabbits. No signs of irritation were detected at all time points.

Eye irritation was determined in vivo in rabbit eyes. Only the conjuntivae show transient mild effects. No ocular efffects were detected.

Justification for selection of skin irritation / corrosion endpoint:
Only available study

Justification for selection of eye irritation endpoint:
Only available study

Justification for classification or non-classification

no classification

No relevant irritation effects were detected on skin or eyes of rabbits after single applications.