4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 30 to July 8, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline test with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

BM1-resin

IUPAC Name:

BM1-resin

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identity : BM 1 -resin
Lot number/Batch number:5003-2
Expiry : January 1996
Composition: > 98 % Epoxide resin based on Bisphenol A and epichlorohydrin, blocked with paraphenyl phenol
Appearance: Yellowish powder
Storage conditions: Room temperature
Date received: 9 June 1994

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

ANIlMAL MANAGEMENT
Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
The animals were in the weight range of 2.2 to 3.3 kg and approximately 10 to 14 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in plastic cages with perforated floors in Building R 14 Room 1.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms. Results of routine physical and chemical examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly sumrnaries.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30 - 70%. These environmental Parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage, was identified by a coloured labe1 displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye remained untreated and used as control.

Amount / concentration applied:

Approximately 63 mg of the test substance, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid of one eye of each animal.

Duration of treatment / exposure:

one second

Observation period (in vivo):

1h, 1, 2, 3, 4, 7 days after instillation

Number of animals or in vitro replicates:

3

Details on study design:

The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
Clinicai signs
All animals were observed daily for signs of ill health or toxicity.
Exarnination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld light.
Ocular irritation was assessed using the prescribed numerical System:
Cornea
Opacity: 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
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Area of cornea involved
Zero 0
One quarter (or less) but not Zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 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 the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal : 0
Some blood vessels definitely hyperaemic (injected) : 1
Diffuse, crimson colour, individual vessels not easily discernible :2
Diffuse beeQ red : 3
Chemosis (iids andlor nictating membranes)
No swelling :0
Any swelling above normal (includes nictating membranes) : 1
Obvious swelling with partial eversion of lids : 2
Swelling with lids about half-closed : 3
Swelling with lids more than half-closed : 4
Any other lesion not covered by this scoring System, was described.

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:

8

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

Basis:

animal #1

Time point:

other: one hour

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 4 day

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: day 4

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 2

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: day 3

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 day

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: day 3

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 3

Irritant / corrosive response data:

No corneai darnage or iridiai inflammation was observed.
A diffuse crimson colouration of the conjunctivae was seen in one animal one hour after instillation only .
Temporary mild conjunctival reactions only were Seen in the remaining animals.
The eyes were normal 3 or 4 days after instillation.

Other effects:

CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Test article caused only mildly irritating to rabbit's eyes based on the results in this study.

Executive summary:

A study was performed to assess the eye irritation potential of BM1-resin to the rabbit. The method followed was that described in

OECD Guideline for Testing of Chemicais No. 405.

Three rabbits were each administered a single ocular dose of 63 mg of the test substance for one second and observed for seven days after instillation. A single instillation of test substance into the eye of the rabbit elicited transient mild conjunctivai irritation only. All reactions had resolved 3 or 4 days after instillation. Test substance can therefore be considered to be only mildly irritating. Test substance shall not be classified for eye irritation in accordance with CLP (Regulation EC No.1272/2008).