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Diss Factsheets

Toxicological information

Eye irritation

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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

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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
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
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.