1-chloro-4-(n-propoxy)-5-thioxanthen-10-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-chloro-4-(n-propoxy)-5-thioxanthen-10-one

EC Number:

415-890-1

EC Name:

1-chloro-4-(n-propoxy)-5-thioxanthen-10-one

Cas Number:

142770-42-1

Molecular formula:

C16H13ClO2S

IUPAC Name:

1-chloro-4-propoxy-9H-thioxanthen-9-one

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna (UK)
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 3.2 - 3.5 kg
- Housing: individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

63 g

Duration of treatment / exposure:

only one exposure

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iradial or conjunctival inflammation.
One animal was treated in advance of the others, to ensure that if a severe response was produced, no furthe animals would be exposed.
Aproximately 63 mg of the test substance, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.

All animals were observed for signs of ill health or toxicity.
Examination of the eyes was made after 1 hour, and 1, 2, 3 (equivalent to 24? 48, 72 hours after instillation) and 4 days after instillation. Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Temporary mild conjunctivial irritation (chemosis, redness) one hour after exposure (minimal score of 1), full reversible 24h after exposure.
No corneal damage or iridial inflammation was observed.

Other effects:

There were no signs of toxicity or ill health.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not eye irritating

Conclusions:

Based on these results, the test item is considered to slighlty irritating but not classified according to the CLP or GHS criteria.

Executive summary:

A study was performed to assess the eye irritation potential of CPTX to the rabbit. Three rabbits were each administered a single ocular dose of 63 mg of the test substance and observed for a maximum of four days after instillation. A single instillation of CPTX into the eye of the rabbit elicited transient mild conjunctival inflammation only. All reactions had resolved one to two days after instillation. Based on these results, the test item is considered to slighlty irritating but not classified according to the CLP or GHS criteria.