Reaction mass of 1,2-Benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2-Benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), Sodium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Produkt SPS

IUPAC Name:

Produkt SPS

Details on test material:

- Name of test material (as cited in study report): Produkt SPS
- Physical state: solid, white
- Analytical purity: Trisodium 4-sulphonophthalate: 25.5 g/100 g; Trisodium 3-sulphonatophthalate: 7.6 g/100 g; Disodium phthalate: 1 g/100 g; Sulphate: 60.6 g/100 g; Water: 4.8 g/100 g; Sum: 99.5 g/100 g; Determined by 1H-NMR-analysis
- Lot/batch No.: 78522224U0
- Expiration date of the lot/batch: December 10, 2012
- Storage condition of test material: RT

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 3 months
- Weight at study initiation: 2.31-2.68 kg
- Housing: single housing
- Diet: STANRAB (P) SQC ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ±3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye served as control

Amount / concentration applied:

0.1 mL bulk volume (about 18 mg of the comminuted test item) was applied to the right eye

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 females

Details on study design:

About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe; reading were done after 1, 24, 48 and 72 h

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean of 24, 48, 72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No reactions at cornea or iris were observed in any of the animals. Slight conjunctival redness and chemosis (grade 1) were noted in two out of three animals 1 hour after application. Conjunctival redness persisted in one of these animals until hour 24.
Slight discharge (grade 1) was noted in all animals at the 1-hour reading only. Additional findings like injected scleral vessels in a circumscribed area were noted in two animals at the 1-hour reading.
The ocular reactions were reversible in all animals within 48 hours after application at the latest.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the described ocular reactions as well as the average score for irritation, Produkt SPS (multikonstituenter Stoff) does not show an eye irritating potential under the test conditions chosen.