Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

9th September 1985 to 16th September 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study is conducted by recognised test house, to experimental procedure in compliance with OECD Guideline 402 and Annex V of the 6th Amendment of the EEC Directive 79/831/EEC - Part B: Methods for the determination of toxicity B5 Eye Irritation. Full data set and rationale provided. GLP compliance not specified, although report is subject to Quality Assurance Procedure.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

and method B5, Annex V 79/831/EEC

Deviations:

no

GLP compliance:

not specified

Remarks:

No mention of GLP is made within the report; however the report was subject to Quality Assurance at the laboratory where the testing was conducted. As such, it is assumed that the principles of GLP were followed

Test material

Test material information

Constituent 1

Reference substance name:

Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

EC Number:

403-360-0

EC Name:

Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Cas Number:

42405-40-3

Molecular formula:

C30H42O6Zn

IUPAC Name:

bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Details on test material:

- Name of test material (as cited in study report): Bontron E-84
- Substance type: Solid
- Physical state: White powder
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not specified
- Lot/batch No.: No batch number is specified within the report, but the test substance is deemed equivalent based on history of manufacture and use.
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperatures

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, England
- Age at study initiation: Approximately 9 to 11 weeks
- Weight at study initiation: 2.0 to 2.3 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Standard Rabbit diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: Timescale unspecified, although report details that rabbits selected for the study were all acclimated to the laboratory environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700-1900 hours) in each 24 hour period


IN-LIFE DATES: From: 9th September 1985 To: 16th September 1985

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 65mg portion of the sample as supplied, occupying a volume of 0.1ml placed into the lower everted lid of one eye of each animal under test.
- Concentration (if solution): N/A – applied as supplied.

VEHICLE
- Amount(s) applied (volume or weight with unit): N/A – applied as supplied.
- Concentration (if solution): N/A – applied as supplied.
- Lot/batch no. (if required): N/A – applied as supplied.
- Purity: N/A – applied as supplied.

Duration of treatment / exposure:

7 days

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable; test material not removed.
- Time after start of exposure: Not applicable.


SCORING SYSTEM:
Examination of the eyes was made after 1 hour and 1,2,3,4 and 7 days after instillation. Grading and scoring of the ocular lesions were performed using the recognised scoring system as follows:

Cornea: degree of density (area most dense taken for reading)

No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured:2
Nacrous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4

Iris

Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

Conjunctivae:

Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse, beefy red: 3

Chemosis (lids and/or nictitating membranes)
No swelling: 0
Any swelling above normal (includes nictitating membranes): 1
Obvious swelling wth partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4

Other lesions not described by the above scoring system where also to be described.


TOOL USED TO ASSESS SCORE: Hand held torch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

Redness noted

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Very slight transient conjunctival reactions were observed at the one hour stage only.

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

Redness noted

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Very slight transient conjunctival reactions were observed at the one hour stage only.

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

Redness noted

Time point:

other: 1 hour

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Very slight transient conjunctival reactions were observed at the one hour stage only.

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

0

Remarks on result:

other: No effects noted in any animal

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

0

Remarks on result:

other: No effects noted in any animal

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

0

Remarks on result:

other: No effects noted in any animal

Irritant / corrosive response data:

None of the animals gave a "positive" reaction.
No corneal damage or iridial inflammation was seen in any of the animal throughout the seven day observation period.
Very slight transient conjunctival reactions were observed at the one hour stage only. Effects were no longer present at 24 hours.

Other effects:

None

Any other information on results incl. tables

Rabbit no and Sex	Region of the Eye		One hour	Day after installation					Result Positive (+) Negative (-)
556F	Cornea		0	1	2	3	4	7	-
	Iris		0	0	0	0	0	0
	Conjunctivae	Redness	1	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
557M	Cornea		0	0	0	0	0	0	-
	Iris		0	0	0	0	0	0
	Conjunctivae	Redness	1	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
570F	Cornea		0	0	0	0	0	0	-
	Iris		0	0	0	0	0	0
	Conjunctivae	Redness	1	0	0	0	0	0
		Chemosis	0	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:

Based on the expermimental study data, the substance is not deemed to be classified as an irritant to the eye. No associated risk phrase is therefore appropriate.

Executive summary:

The ocular irritation of the test substance was assessed using three New Zealand White rabbits. Minimal conjunctival reactions were noted in each animal that was reversible within 24 hours of exposure. Based on the study data, the substance is considered to be non-irritant to the eye.