Reaction products of diazotised m-phenylendiamine, subsequently coupled with diazotised 4-aminobenzene-1-sulfonic acid, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

supporting study

Study period:

March 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP compliant, the subsatance is salified with ammonium salt instead than sodium

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: REAL DECRETO 363/1995, 10 march

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

similar substance 3

IUPAC Name:

similar substance 3

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:authorized supplier.
- Weight at study initiation:2341-2454g
- Housing:Housing: Stainless steel single cage
- Diet : daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water :filtered tap water (5 µm) , ad libitum
- Acclimation period:7 days
- Health check: during observation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2°C
- Humidity (%):55 ± 25%
- Air changes (per hr):15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod : 12 hour cycle dark/light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.1 g

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1,24,48,72 hours and 7,14,21 days

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM:cornea, iris, conjunctiva, (edema) Chemosis

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0.22

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0.775

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0.22

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The tested substance is classified not irritant for eyes

Executive summary:

Direct Brown 44 ammonium salt has been tested for eye irritation with 3 New Zealand white rabbits according to Royal decree 363/1995 . After 72 hours of observation no rabbits show any signs of damage. The substance is classified as non-irritating to the eyes.