Registration Dossier

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridine-2-thiol 1-oxide, sodium salt
EC Number:
223-296-5
EC Name:
Pyridine-2-thiol 1-oxide, sodium salt
Cas Number:
3811-73-2
Molecular formula:
C5H5NOS.Na
IUPAC Name:
sodium (1-oxo-1lambda5-pyridin-2-yl)sulfanide
Details on test material:
- Analytical purity: 40%
- Lot/batch No.: 6RC190016

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
-Source: Ace Animals
Weight: 2.4kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount: 0.1ml
Duration of treatment / exposure:
24h
Observation period (in vivo):
14d
Number of animals or in vitro replicates:
6
Details on study design:
-Scoring system: Draize Scale
-Examination times: 1h, 1, 2, 3, 7, 14 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Throughout test
Score:
0
Max. score:
0
Reversibility:
other: not relevant
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Throughout study
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Cleared by day 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Throughout study
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Cleared by day 14
Other effects:
There was no corneal opacity noted at any observation period. Iritis, noted in 6/6 eyes, cleared by Day2. Conjuctival irritation, noted in 6/6 eyes, cleared by Day 14.
Three animals died by Day 2 with predeath signs of lethargy, prostration, soiling of the anogenital area, convulsions, tachypnea, ataxia, and wetness of the nose/mouth area. Physical signs noted in survivors included lethargy, yellow nasal discharge, and yellow staining of the nose/mouth area.
Necropsy of the animals that died during the study revealed abnormalities of the lungs, peritoneal cavity, and gastrointestinal tract, as well as wetness of the nose/mouth area and yellow nasal discharge.

Applicant's summary and conclusion

Conclusions:
The test article produced irritation which cleared within 14 days. However, the physical signs and mortality produced by the application indicates that the material is toxic to rabbits via this route. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.