Trisodium 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,5-trisulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-07-04 to 1989-10-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24th February 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,5-trisulphonate

EC Number:

274-349-4

EC Name:

Trisodium 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,5-trisulphonate

Cas Number:

70161-14-7

Molecular formula:

C20H16ClN9O10S3.3Na

IUPAC Name:

trisodium 7-({4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-(carbamoylamino)phenyl}diazenyl)naphthalene-1,3,5-trisulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Orange 12

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult
- Females were nulliparous and not pregnant
- Weight at study initiation: Females: 2.4 – 2.9 kg
- Housing: standardized conventional conditions in individual stainless steel cages. Excrement trays beneath the cages contained low-dust wood shavings (type S 8/18, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Identification of animals: The rabbits were identified by individual ear marks (tattoos) and cage marks.
- Diet (e.g. ad libitum): Diet “Ssniff K4” (Ssniff Spezialdiäten GmbH, Soest, Germany); approx. 100 -120 g per animal and day; feeding once per day in the morning.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: The animals were kept for at least 14 days in the quarantine station of the Department of Laboratory Animal Services before treatment and monitored for diseases (clinical). Shortly after arrival collective faeces specimens were examined for Coccidia oocysts .

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single treatment, 24 h after instillation the treated eye was washed with physiological saline

Observation period (in vivo):

Scoring was conducted after 1, 24, 48, 72 hours and 7 days after treatment

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours after instillation

SCORING SYSTEM: according to Draize (see Table 1 in box "Any other information on material and methods incl. tables")

TOOL USED TO ASSESS SCORE: optical tools and fluorescin

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No corneal or iridial effects were noted in any treated eye during the study period. For individual results see table 2 in box "Any other information on results incl. tables".

Any other information on results incl. tables

Table 2: Individual Eye Irritation Scores

	24 hours				48 hours				72 hours				Mean 24/48/72 hours
Animal no.	Cornea	Iris	Conjunctivae	Chemosis	Cornea	Iris	Conjunctivae	Chemosis	Cornea	Iris	Conjunctivae	Chemosis	Cornea	Iris	Conjunctivae	Chemosis
1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute eye irritation/corrosion study according to OECD 405, the test substance does not cause irritant effects in the rabbit eye.

Executive summary:

In a primary eye irritation study conducted according to OECD 405, the test item was instilled into the eye of 3 female New Zealand White rabbits. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

No corneal or iridial effects were noted in any treated eye during the study period.

In this study, the test item is not an eye irritant according to CLP criteria.