Reactive Orange 16

Endpoint summary

Description of key information

not skin and eye irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

other: read across from similar substance

Adequacy of study:

weight of evidence

Study period:

From August 27,1985 to October 10,1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant with international guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1-3.3 kg
- Housing:in air-conditioned room in individual cages (battery cages)
- Diet : Altromin 2123 - Rabbit Altromin GmbH
- Water : deionized water, chlorinated water ad libitum from automatic drinking

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 3 °C
- Humidity (%):50 ± 20 %
- Photoperiod : 12 hours cycle dark/light

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

physiological saline

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount: 500 mg

Duration of treatment / exposure:

4 hours

Observation period:

30 min , 60 min , and 24, 48, 72 hours later and 7, 14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure:25 cm^2
- Type of wrap if used:semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with water


SCORING SYSTEM: erythema , edema

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hrs

Score:

ca. 0.8

Max. score:

4

Reversibility:

fully reversible within: 24 Hrs

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 Hrs

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Reactive Orange 16 similar substance 1 is non-irritating and is not subject to classification.

Executive summary:

The skin irritation test in rabbits showed that the similar substance 1 in this study, based on the criteria for classification Directive 83/467/EEC , is non-irritating and is not subject to classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation, other

Remarks:

in vivo

Type of information:

other: read across from similar substance

Adequacy of study:

weight of evidence

Study period:

Since August 27,1985 to August 30,1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliance with international guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: 83/467/EWG: 29 july 1983

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 3,1 - 3,2 kg
- Housing: fully air-conditioned rooms in individual cages (battery cages)
- Diet: Altromin 2123 maintenance diet - Rabbits, ad libitum
- Water: deionized water, chlorinated water from the tables and drank ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ±20 %
- Photoperiod: 12 hours cycle dark/light

Vehicle:

water

Remarks:

isotonic salt solution

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Concentration: 100 mg in conjunctival sac of left eye

VEHICLE
- Amount(s) applied: 0.1 ml
- Source: Fresenius AG

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48, 72 hours and 7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with water

SCORING SYSTEM: according to OECD 405 (cornea, iris, conjunctiva)

TOOL USED TO ASSESS SCORE: fluorescein (evaluation at 24 and 72 hours)
24 hours before the start of the study were treated to the sight of animals after instillation of one drop of sodium fluorescein (0.01%) are examined under ultraviolet light for any damage to the cornea. There were only taken in experimental animals, whose eyes have not shown results.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 Hrs

Score:

ca. 0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 h

Score:

ca. 0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Table of individual data:

time after administration	1h			24h			48h			72h
n° of animals	1	2	3	1	2	3	1	2	3	1	2	3
conj. Chemosis	0	0	0	0	0	0	0	0	0	0	0	0
conj. redness	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0	0	0	0
Cornea opacity	0	0	0	0	0	0	0	0	0	0	0	0
fluorescien test				0	0	0				0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The eye irritation test in rabbits showed that the similar substance 1, on the present study according to the classification criteria of Directive 83/467/EEC, is non-irritating and is not subject to classification.

Executive summary:

The eye irritation test in rabbits showed that the similar substance 1, on the present study according to the classification criteria of Directive 83/467/EEC, is non-irritating and is not subject to classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

All studies confirm that Reactive Orange 16 is not irritant for skin, eye and respiratory tract.

Justification for classification or non-classification

Based on regulation 1272 -2008 "Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application." All study results indicate that reactive orange 16 doesn't show any effect on eye. No classification is necessary.

Based on 1272 -2008 regulation, table 3.2.2 (concerning skin irritation) the results are to low for classification and are fully reversible within 24h. No classification is necessary.