Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate

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:

other: see 'Remark'

Remarks:

Non-GLP non-guideline study, available as unpublished report, predates implementation of GLP and/or development of study guidelines, notable limitations in design and/or reporting. After application eye lids were held open for a few seconds instead of closed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12

Version / remarks:

February 1965

GLP compliance:

no

Remarks:

Study performed before GLP principles were implemented.

Test material

Test material information

Constituent 1

Reference substance name:

Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate

EC Number:

229-142-3

EC Name:

Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate

Cas Number:

6417-83-0

Molecular formula:

C21H12N2O6S.Ca

IUPAC Name:

calcium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)diazenyl]-2-naphthoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 3-4 months
- Weight at study initiation: male 2.54 kg and female 2.46 kg
- Housing: single
- Diet: a commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: sterile filtered water was available at all times
- Acclimation period: one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): artificial light for 10 hours daily from 08.00 - 18.00 hours

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the eyes of three of the rabbits with warm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24 h

Score:

0.17

Max. score:

3

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

The mean score for redness at one and six hours after instillation was 1 (maximum 3). The mean score for chemosis at one and six hours after instillation was 0.17 (maximum 4). The mean score for discharge at one hour after instillation was 1 (maximum 3) and 0.17 after six hours. This was fully reversed after 2 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an in vivo eye irritancy study study with 6 New Zealand White rabbits, the substance is found to be not irritating to eyes.

Executive summary:

In an eye irritation test 6 New Zealand White rabbits received 100 mg of the test substance into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held closed for one second. The right eye served as a control. After 30 seconds the treated eyes of three rabbits were each rinsed with warm water for 1 minute after treatment. The rabbits were examined 1, 6, 24, 48 and 72 hours after application. A minimal conjunctival reaction was seen in all eyes one hour after treatment. From 6 hours onwards this regressed and all eyes were normal by 48 hours. Based on these results, the substance does not have to be lassified for eye irritant properties.