Registration Dossier

Toxicological information

Eye irritation

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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4. for Bisphenol A.

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
Three male animals from a laboratory supplier, approximately 7-9 months of age with initial body weights of 2.3-2.4 kg were used. Standard rabbit diet of Altromin 2023 (ALTROMIN GmbH, D-32791 Lage/Lippe) was supplied ad Libitum. Drinking water was offered ad libitum before and after the exposure period. The animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, D-16352 Schonwalde). the animals were acclimated at least 20 days. The Environmantal conditions were as follows: -Temperature, 17-23 degrees C, -Humidity, 30-70%, -Photoperiod, 12 hours light (150 lux at approximately 1.5 meter room height)/12 hours dark.

Test system

Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
The test substance was ground to a fine dust and 100 mg was used per animal.
Duration of treatment / exposure:
Single instillation into the conjunctival sac, no wash-out.
Observation period (in vivo):
28 days
Number of animals or in vitro replicates:
Three males
Details on study design:
Three male Himalayan rabbits were treated with 100 mg test substance by a single instillation into the conjunctival sac of the right eye. The eye lids were then gently held together for one second to prevent loss of the material. The left eye, which remained untreated, served as a control. The eyes of the animals were not rinsed. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, and 72 hours and 4 to 28 days after administration. The eye reactions were observed and recorded At 24 hours, 7, 14, and 28 days after administration, the eyes were treated with Fluorescein SE Thilo eye drops (Alcon Pharma GmbH, D-79108, Freiburg, Germany) and examined for trama.

Results and discussion

In vivo

Results
Irritation parameter:
chemosis score
Basis:
animal: One animal only exhibited this score.
Time point:
other: One hr to day four.
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: All other scores were graded 1.
Irritant / corrosive response data:
Corneal opacity (grade 1) was observed in all three animals 1 hour to 9 days after instillation; in animal #2 until 13 days; and in animal #3 until 28 days after instillation. The fluorescein test performed after 24 hours revealed corneal staining in all 3 rabbits (whole surface). The fluorescein test performed after 7 days revealed corneal staining in animal #1 and animal #2 (3/4 of the corneal surface) and in animal #3 (whole surface). The fluorescein tests performed after 14 and 21 days revealed corneal staining in animal #3 (1/2 of the corneal surface). An irritation of the iris (grade 1) was observed in all three animals one hour to 9 days after instillation, and in animal #2 until 11 days and in animal #3 until 28 days after instillation. Conjunctival redness (grade 1) was observed in all animals one to 24 hours after instillation, in animal #2 until 4 days and in animal #3 until 6 days after instillation. Conjunctival chemosis (grade 1) was observed in animal #1 and animal #2 24 hours after instillation and in animal #3 one hour to 4 days (grade 2) and 5 and 6 days (grade 1) after instillation. Whitish deposits in the conjunctival sac (probably pus) were observed in animal #2 and animal #3 from 72 hours to 5 days after instillation.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Based primarily on the persistence of the occular lesions observed including corneal opacity the test substance is considered to be irritating to the rabbit eye. However, mean ocular lesion scores are insufficient for Classification and Labeling. These data for the structural analog, Bisphenol A, suggest that 2-Acetone polymer with phenol (BPA-Tars) may be an eye irritant.
Executive summary:

A structural analog of 2 -Acetone polymer with phenol (BPA-Tars), Bisphenol A, was evaluated for eye irritation potential by an O.E.C.D. No. 405 Test Guideline study conducted with GLP compliance. Based primarily on the persistence of the occular lesions observed including corneal opacity the test substance is considered to be irritating to the rabbit eye. However, mean ocular lesion scores are insufficient for Classification and Labeling. These data for the structural analog, Bisphenol A, suggest that BPA-Tars may be an eye irritant.