Amines, C12-14-tert-alkyl, compds. with 1-[2-[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]diazenyl]-2-naphthalenol 1-[2-[2-hydroxy-4(or 5)-nitrophenyl]diazenyl]-2-naphthalenol chromium complexes

Endpoint summary

Description of key information

The test substance is not irritating or corrosive to the rabbit skin (OECD 404, GLP). 
The test substance is not irritating to the rabbits eye (OECD 405, GLP).

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:

29 Sept. - 02 Oct. 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13 weeks
- Weight at study initiation: 2447 - 2628
- Housing: plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20 °C
- Humidity (%): 50 - 75 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 29. September to 02. October 1988

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

water

Controls:

no

Amount / concentration applied:

Three portions of 0.5 gram of the test substance were transferred into glass vials. Prior to treatment each portion was moistened with 0.5 ml Milli-RO water. Immediately thereafter, each portion of the prepared test substance was spread on a 6 cm^2 patch of Metalline and mounted on permeable tape.

Duration of treatment / exposure:

4 hours

Observation period:

Approximately 55 min, 24 hrs; 48 hrs; 72 hrs and additionally on day 4 after removal of the patches.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 10 cm x 10 cm
- Type of wrap if used: The animals were wrapped in flexible bandage

REMOVAL OF TEST SUBSTANCE
The remaining test substance was removed using a dry tissue subsequently a tissue moistened with tap-water

SCORING SYSTEM:
The exposed skin areas were examined for signs of erythema and oedema and the responses were scored (according to the grading system given in the OECD guideline 404) approximately 55 minutes, and 24, 48 and 72 hours and 4 days after removal of the patches. For reference the control site on the contralateral flank was used. In order to facilitate the scoring, the skin area concerned of all animals was shaved again at least 5 hours before observation on day 1.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean (24+48+72h)

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean (24+48+72h)

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: day 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean (24+48+72h)

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean (24+48+72h)

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: day 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean (24+48+72h)

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean (24+48+72h)

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: day 4

Table 1: Primary skin irritation scores

	time	animal 1	animal 2	animal 3
erythema	55 min	1	1	1
	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
	4 d	0	0	0
edema	55 min	0	0	0
	24 h	0	0	0
	48 h	1	1	0
	72 h	1	1	1
	4 d	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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:

03. - 10. October 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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: The Broekman Institute, Someren, The Netherlands
- Housing: plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 °C
- Humidity (%): 50 - 75
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 03 - 10 October 1988

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.07 g of the test substance (corresponding to 0.1 ml)

Observation period (in vivo):

Examination of the eyes after 1 hour and 1, 2, 3, and 7 days after instillation of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein (2% solution in water)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24+48+72h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24+48+72h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24+48+72h

Score:

0.77

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24+48+72h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48h

Table 1: Eye irritation scores of the test substance

	time	animal 1	animal 2	animal 3
corneal opacity	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
iris	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
conjunctivae	24 h	2	1	1
	48 h	1	1	0
	72 h	1	0	0
chemosis	24 h	1	1	0
	48 h	0	0	0
	72 h	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

In a primary dermal irritation study conducted according to OECD 404 and GLP, three NZW rabbits were dermally exposed to the test substance for 4 hours. Animals then were observed for three days and additional observations were made on day 4. The single semi-occlusive application elicited very slight oedema in all animals at the 48 and/or 72 hour reading, but no erythema. All reactions had resolved by day 4. The observed signs of skin irritation were not relevant for classification and labelling.

Eye irritation:

In a primary eye irritation study according to OECD TG 405 and GLP, 0.07g of the test substance was singly instilled into the rabbits eye. 24 hrs after exposure, the maximum response observed was grade 2 reddening of the eyelids of one rabbit, while the two other animals showed very slight reddening. Very slight chemosis was observed during the first 24 hours. All animals showed lacrimation in response to the test substance (maximum at 24 hours), while the treated eyes stained intensely black. No adverse effects to the cornea and the iris were observed in any of the animals during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any corneal epithelial damage. No signs of systemic intoxication were observed in any of the rabbits. All reactions had resolved 7 days after instillation.

Justification for classification or non-classification

Based on the results of the skin and eye irritation key toxicity studies, the test substance is not subject to classification and labelling for skin irritation or eye irritation according to Directive 67/548/EEC and Regulation 1272/2008/EC.