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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
Study period:
Test phase 2013-05-13 to 2013-04-08. Report complete 2013-06-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate
EC Number:
700-787-7
Cas Number:
769953-18-6
Molecular formula:
C11H9N2O3S2Li
IUPAC Name:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation:2.40 and 3.07 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Free access to food throughout the study
- Water (e.g. ad libitum): Free access to mains drinking water throughout the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: a 0.1ml volume of the test material which was found to weigh approximately 74mg as measured by gently compacting the required volume into an adapted syringe
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: None

SCORING SYSTEM: Initial pain reaction assessed using a six point scale.Assessment of ocular damage at 1h, 24, 48 & 72h according to the numerical evaluation given in Draize (Draize, J.H, 1977). A modified version of the system described by Kay J.H. and Calandra J.C. (1962) was used to classify the ocular irritancy potential of the test material.

TOOL USED TO ASSESS SCORE: light source from a standard opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 73100
Time point:
other: highest score at 24, 48 & 72h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 73154
Time point:
other: highest score at 24, 48 & 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 73100
Time point:
other: highest score at 24, 48 & 72h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 73154
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal: 73100
Time point:
other: highest score at 24, 48 & 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal: 73154
Time point:
other: highest score at 24, 48 & 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: redness
Basis:
animal: 73100
Time point:
other: highest score at 24, 48 & 72h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: redness
Basis:
animal: 73154
Time point:
other: highest score at 24, 48 & 72h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73100
Time point:
other: 1h
Score:
12
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73154
Time point:
other: 1h
Score:
12
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73100
Time point:
other: 24h
Score:
10
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73154
Time point:
other: 24h
Score:
15
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73100
Time point:
other: 48h
Score:
6
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73154
Time point:
other: 48h
Score:
6
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73154
Time point:
other: 72h
Score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73100
Time point:
other: 7 days
Score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73154
Time point:
other: 7 days
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
animal: 73100
Time point:
other: 14 days
Score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
animal: 73154
Time point:
other: 14 days
Score:
0
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
A single application of the test material to the non-irrigated eye of two rabbits produced iridial inflammation, moderate conjunctival irritation and petechial haemorrhage on the nictitating membrane. Both treated eyes appeared normal at the 14 day observation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 12.5 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

Introduction

This study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White Rabbit. The study was designed to be compatible with the following guidelines:

- OECD Guidelines for the Testing of Chemicals No. 405 'Acute Eye Irritation/Corrosion' (adopted 02 October 2012)

- Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008.

Results

A single application of the test material to the non-irrigated eye of two rabbits produced iridial inflammation, moderate conjunctival irritation and petechial haemorrhage on the nictitating membrane. Both treated eyes appeared normal at the 14 day observation.

Conclusion

The test material produced a maximum group mean score of 12.5 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

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