Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Relatively well reported study. Observation period 8 days instead of 21 days.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

observation period of 8 days instead of 21 days; sex unknown

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts

EC Number:

283-041-9

EC Name:

Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts

Cas Number:

84539-53-7

Molecular formula:

non specified (UVCB substance)

IUPAC Name:

non specified (UVCB substance)

Details on test material:

- Name of test material (as cited in study report): Bolikel FE
- Physical state: a brown/red crystaline powder
- Lot/batch No.: Batch No. 2
- Storage condition of test material: at ambient temperature, under dry conditions
- Other: received on February 27, 1987 (4 x 375 g)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: at least 3 months old
- Weight on arrival: 2.29-2.38 kg
- Weight at study initiation: 3.08-3.67 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): free access (to S.Q.C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England)
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (range 15 - 23)
- Humidity (%): 55 (range 40 - 70)
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per day


IN-LIFE DATES: From: May 11, 1987 To: May 19, 1987

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g test material
- Concentration (if solution): not applicable

Duration of treatment / exposure:

Single application (the eyelids were gently held together for one second and then released. The left eye remained untreated).

Observation period (in vivo):

8 days (1 hour, 24, 48 and 72 hours and on Day 8)

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: see below (additionally an assessment was made for the pain response)

TOOL USED TO ASSESS SCORE: ophthalmoscope and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

1.78

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 3 days

Irritant / corrosive response data:

No

Other effects:

No

Any other information on results incl. tables

Summary of ocular lesions

Anim. No.	Effect	Hours	Days after application					Mean score cornea Days 1/2/3	Mean score iritis Days 1/2/3	Mean score redness Days 1/2/3	Mean score chemosis Days 1/2/3
		1	1	2	3	8	14
504M	Cornea Iris Redness Chemosis	2 1 1 1	0 1 2 0	0 0 2 1	0 0 1 0	0 0 0 0	- - - -	0	0.33	1.67	0.33
511M	Cornea Iris Redness Chemosis	0 1 2 0	0 0 2 0	0 0 2 0	0 0 1 0	0 0 0 0	- - - -	0	0	1.67	0
512M	Cornea Iris Redness Chemosis	0 1 2 1	0 1 2 1	0 1 2 0	0 0 2 0	0 0 0 0	- - - -	0	0.67	2	0.33
Mean all anim.								0	0.33	1.78	0.22

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the results of the present study, it was concluded that the test compound, Bolikel FE, induced a reversible very slight eye irritation. So the test material was a ‘non-irritant’ to the eye and therefore not classifiable according to OECD-GHS.

Executive summary:

A study was conducted to assess the irritancy potential of Bolikel FE to the eye of three New Zealand Albino rabbits. The study was performed according to OECD Guideline 405 (Acute Eye Irritation/Corrosion) and also according to Good Laboratory Practice Standards.

A single application of 0.1 g of the test material to the right eye of the rabbit produced redness of the conjunctivae, slight chemosis and iridial congestion were observed amongst all three animals during the first 24 hours. Translucency of up to one-quarter of the cornea was also apparent in one rabbit at the one hour examination. Only injection of the conjunctival blood vessels was observed at the 72-hour examination and all ocular lesions had resolved by Day 8.

Based on the results of the present study, it was concluded that the test compound, Bolikel FE, induced a reversible very slight eye irritation. So the test material was a ‘non-irritant’ to the eye and therefore not classifiable according to OECD-GHS.