Barium bis[2-[(2-hydroxy-1-naphthyl)azo]benzoate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

According to OECD and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

84/449/EEC

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

EC Number:

225-935-3

EC Name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

Cas Number:

5160-02-1

Molecular formula:

C17H13ClN2O4S.1/2Ba

IUPAC Name:

barium bis{5-chloro-2-[(2-hydroxy-1-naphthyl)diazenyl]-4-methylbenzenesulfonate}

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Animal specifics: New Zealand White, conventional breed
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.5 kg to 2.8 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the right untreated eye of each animal served as control respectively

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

One administration 24 hours

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3

Details on study design:

Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3 each

Time point:

other: mean of the 24, 48 and 72 hours reading

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since on effects occured

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3 each

Time point:

other: mean of the 24, 48 and 72 hours reading

Score:

0

Max. score:

2

Reversibility:

other: reversibility not relevant since no effects occured

Results 3

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3 each

Time point:

other: mean of the 24, 48 and 72 hours reading

Score:

0

Max. score:

4

Reversibility:

other: grade 2 (2 anmials) and 1 (1 animal) was observed 1 hour after administration and was fully reversible within 24 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 each

Time point:

other: mean of the 24, 48 and 72 hours reading

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean of the 24, 48 and 72 hours reading

Score:

0

Max. score:

3

Reversibility:

other: grade 1 was observed 1 hour after administration and was fully reversible within 24 hours

Irritant / corrosive response data:

1 hour after administration injected vessels up to diffuse crimson red colour and slight swelling of conjunctivae was observed in all animals. All signs of irritation were fully reversible after 48 h.

Other effects:

Red staining of eye discharge was observed at 1 hour after application.

Any other information on results incl. tables

Animal	Evaluation interval (after application)	Opacity of cornea	Redness of conjunctiva	Chemosis of conjunctiva	Iris	Red eye discharge	Fluoresceinestaining
# 1	1 hour	0	2	2	0	x
# 2		0	2	2	0	x
# 3		0	1	1	0	x
# 1	24 hours	0	1	0	0		0
# 2		0	1	0	0		0
# 3		0	0	0	0		0
# 1	48 hours	0	0	0	0
# 2		0	0	0	0
# 3		0	0	0	0
# 1	72 hours	0	0	0	0		0
# 2		0	0	0	0		0
# 3		0	0	0	0		0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a OECD guideline and GLP compliant primary eye irritation test in rabbits mean scores for cornea, iris and chemosis of conjunctiva were 0 for all animals. Mean scores for redness of conjunctiva were 0.3 for two and 0 for one animal. All signs of irritation were fully reversible after 48 h.

Therefore, the test item has not to be classified according to Regulation (EC) No 1272/2008.

Executive summary:

A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.

One and 24 hours after treatment the conjunctivae of the animals showed injected blood vessels up to a diffuse crimson red colour. Additionally, a slight swelling and slight from substance coloured eye discharge were observed in the animals one hour after treatment. Mean scores for cornea, iris and chemosis of conjunctiva were 0 for all animals. Mean scores for redness of conjunctiva were 0.3 for two and 0 for one animal. 48 hours after treatment all signs of irritation were reversible.

Therefore, the test item has not to be classified according to Regulation (EC) No 1272/2008.