Perboric acid, sodium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-04-28 to 1987-05-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

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:

Sodium Perborate Monohydrate

IUPAC Name:

Sodium Perborate Monohydrate

Details on test material:

-Purity: no data
-Physical state: White granules
-Storage condition of test material: Ambient room temperature and humidity

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
-Source: Clifford Roedel
-Age at study initiation: no data
-Weight at study initiation: no data
-Housing: Single
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled
-Humidity (%): controlled

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye was used as control

Amount / concentration applied:

TEST MATERIAL
-Amount(s) applied (volume or weight with unit): 0.1 mL equivalent of the undiluted test item

Duration of treatment / exposure:

The test item was placed into the conjunctival sac of one eye to each rabbit. No rinsing.

Observation period (in vivo):

Ocular responses were recorded at 1 h post dose and on days 1, 2, 3, 7, 14 and 21.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE: not rinsed

SCORING SYSTEM: according to the Draize

TOOL USED TO ASSESS SCORE: Fluorescein was used to determine corneal effects at 24 hrs.

General health of the animals was monitored at each observation time.

Results and discussion

In vivo

Irritant / corrosive response data:

Details are summarised in the attached file Results.pdf

Any other information on results incl. tables

See attached file Results.pdf

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Sodium Perborate Monohydrate was severely irritating and may have irreversible effects to the eye (corrosive)

Executive summary:

In an eye irritation study according to OECD Guideline 405, 3 rabbits were dosed with 0.1 mL equivalent of undiluted Sodium Perborate Monohydrate, which was placed into the conjunctival sac of one eye each.

The eyes remained unwashed. Ocular responses were assessed up to day 21.

Corneal opacity, noted in 3/3 eyes, persisted to day 21 in 1/3 eyes. Iritis was noted in 3/3 eyes and cleared by day 21. Moderate to severe conjunctival irritation, noted in 3/3 eyes, cleared by day 21 in 2/3 eyes. However, pale areas in the conjunctiva were noted through day 21.

As the effects were irreversible in 1 animal, Sodium Perborate Monohydrate should classified as Category I (serious damage to the eye) according to GHS.