Reaction mass of divinylbenzene and ethylstyrene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of divinylbenzene and ethylstyrene

EC Number:

910-757-7

Cas Number:

N/A

Molecular formula:

Divinylbenzene: C10H10 Ethylstyrene: C10H12

IUPAC Name:

Reaction mass of divinylbenzene and ethylstyrene

Details on test material:

Vapor phase chromatograph (VPC) analysis :
Divinylbenzene 55.7%, Ethylvinylbenzene 40.4%, Diethylbenzene 4.5%, Mass 144-146 1.7%, Naphthalene 0.4%, t-Butyl Catechol 1010 ppm, Polymer 4 ppm

The percentage was determined by measuring the percent area of each component shown in the vapor phase chromatograph and is
considered to be approximately equal to weight percent.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

single exposure, right eye 30 second exposure and then washed, left eye test material instilled and unwashed

Observation period (in vivo):

up to 1 week

Number of animals or in vitro replicates:

3

Details on study design:

Twenty-four hours prior to use, the eyes of three rabbits were examined and established as being without defects or irritation. Approximately 0.1 mL of the liquid material was instilled into the conjunctival sac of the right eye of each of the animals. Following a 30-second exposure period the eye was washed for 2 minutes with tepid, flowing tap water. The liquid material was then instilled in a similar manner into the left eye which was left unwashed. The animals were observed for indications of pain immediately after instillation into each eye. After instillation into the left eye, both eyes were examined for conjunctival irritation, corneal injury and internal effects such as iritis. All eyes were subsequently examined at various intervals up to 1 week post-instillation. At each examination after the first, the eyes were stained with a drop of 5% aqueous fluorescein stain to help evaluate corneal injury. Excess stain was removed by washing in a stream of flowing water.

Results and discussion

In vivo

Results

Results 1

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal: all animals

Time point:

24/48/72 h

Remarks on result:

other: Conjunctival membranes became slightly inflamed immediately after instillation and were still very slightly affected after 8 days.

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal: all animals

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal: all animals

Time point:

24/48/72 h

Remarks on result:

other: not reported

Results 5

Irritation parameter:

chemosis score

Basis:

animal: all animals

Time point:

24/48/72 h

Remarks on result:

other: not reported

Results 6

Irritation parameter:

other: pain response

Basis:

animal: all animals

Time point:

other: upon instillation

Remarks on result:

other: Moderate pain response observed which appeared to intensify after washing.

Irritant / corrosive response data:

Instillation of DVB-55 into the eyes of rabbits resulted in moderate pain response which appeared to intensify after washing. The conjunctival membranes became slightly inflamed immediately after instillation and were still very slightly affected after 8 days. No effects on the cornea and internal structures of the eye were observed.

Other effects:

No data

Applicant's summary and conclusion

Interpretation of results:

other: slightly irritating

Conclusions:

Only slight effects on the conjunctivae were observed after the instillation of DVB-55 into the eyes of rabbits. No effects on the cornea and internal structures of the eye were observed and all effects were resersible within the observation period.

Executive summary:

Twenty-four hours prior to use, the eyes of three rabbits were examined and established as being without defects or irritation. Approximately 0.1 mL of the liquid material was instilled into the conjunctival sac of the right eye of each of the animals. Following a 30-second exposure period the eye was washed for 2 minutes with tepid, flowing tap water. The liquid material was then instilled in a similar manner into the left eye which was left unwashed. The animals were observed for indications of pain immediately after instillation into each eye. After instillation into the left eye, both eyes were examined for conjunctival irritation, corneal injury and internal effects such as iritis. All eyes were subsequently examined at various intervals up to 1 week post-instillation. At each examination after the first, the eyes were stained with a drop of 5% aqueous fluorescein stain to help evaluate corneal injury. Excess stain was removed by washing in a stream of flowing water.

 

Instillation of DVB-55 into the eyes of rabbits resulted in moderate pain response which appeared to intensify after washing. The conjunctival membranes became slightly inflamed immediately after instillation and were still very slightly affected after 8 days. No effects on the cornea and internal structures of the eye were observed.