Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Remarks on result:
probability of mild irritation
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.
Irritation parameter:
cornea opacity score
Basis:
animal: all animals
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
24/48/72 h
Remarks on result:
other: not reported
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
24/48/72 h
Remarks on result:
other: not reported
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.