Esterification products of 4,4'-isopropylidenediphenol, ethoxylated and 2-methylprop-2-enoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From August 16 to 25, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted similarly to OECD Guideline 405 with minor deviations: individual animal weights not reported

Cross-reference

Cross-reference 1

Reason / purpose:

reference to same study

Cross-reference 2

Reason / purpose:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report Date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

individual animal weights not reported

Test guideline 2

Qualifier:

according to

Guideline:

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

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Hampshire, England
- Age at study initiation: Approximately 10-13 weeks
- Weight at study initiation: 2.3-3.1 kg
- Housing: Housed individually in metal cages
- Diet: Standard laboratory diet (SDS Stanrab (P) Rabbit diet), ad libitum
- Water: Drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30-70 %
- Air changes: Approximately 19 air changes/h
- Photoperiod: 12 h dark / 12 h artificial light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

no washing was done

Observation period (in vivo):

7 days
- Examination of the eyes was made after 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h after instillation), 4 and 7 days after instillation.

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

- No corneal damage or iridial inflammation was observed.
- Temporary mild conjunctival reactions only were seen.
- Eyes were normal one day after instillation.

Other effects:

- No signs of toxicity were observed in any animal throughout the observation period.

Any other information on results incl. tables

Table 1: Ocular reactions observed after instillation of Bisphenol A ethoxylated diacrylate

Rabbit number and sex	Region of eye		1 h	Day after instillation
				1	2	3	4	7
2293 * (Female)	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	1	0	0	0	0	0
		Chemosis	1	0	0	0	0	0
2294 (Female)	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	1	0	0	0	0	0
		Chemosis	1	0	0	0	0	0
2295 (Female)	Cornea		0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	1	0	0	0	0	0
		Chemosis	1	0	0	0	0	0

* Pilot animal

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an eye irritation study conducted similarly to the OECD Guideline 405 and in compliance with GLP, 3 healthy female rabbits of the New Zealand White strain were exposed to 0.1 mL of Bisphenol A ethoxylated diacrylate in one eye, while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h), 4 and 7 days after instillation and graded according to the method of Draize (1977). 

No corneal damage or iridial inflammation was observed. Temporary mild conjunctival reactions only were seen. All the eyes were normal one day after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score. In this study, Bisphenol A ethoxylate diacrylate is not an eye irritant on female rabbits.

Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).