m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Based on the proposed guideline of the USEPA § 163.81-4

Principles of method if other than guideline:

The test substance was administered to an eye of (3 male and 3 female) New Zealand White rabbits. The animals were followed for 7 days after exposure and were scored on corneal opacity, iritis, conjunctival redness and chemosis.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

EC Number:

279-213-8

EC Name:

m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

Cas Number:

79665-26-2

Molecular formula:

C32 H30 N2 O8 S2 . C6 H16 N2

IUPAC Name:

m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: minimal 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: yes in 3 of the 6 rabbits, with 10 mL of physiological saline
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Readings were performed on day 1, 2, 3, 4 and 7 after application. Effects on cornea, iris, and conjunctivae were scored. For evaluation, the calculation of the mean values of corneal opacity, iris, conjunctival redness and chemosis for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account.

TOOL USED TO ASSESS SCORE: slit-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: non-washed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: non-washed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: non-washed

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: non-washed

Irritant / corrosive response data:

Eyes that were washed 30 seconds after exposure, also showed no irritant effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met