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

Endpoint summary

Description of key information

Based on the studies on rabbits, 1-chlor-4-(n-propoxy)-5-thioxanthen-10-one is considered to be not skin or eye irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 12-15 weeks
- Weight at study initiation: 2.9 - 3.3 kg
- Housing: individually
- 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

IN-LIFE DATES: From: 17 sept 1991 To: 20 sept 1991

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4h

Observation period:

24h, 48h, 72h

Number of animals:

3

Details on study design:

Approximately 24h prior to application of the test substance, hait was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
1 0.5 g amount of the test substance was applied under a 25 mm x 25 mm gauze pad which had been moistened with 0.5 ml distilled water to one intact skin site on each animal.
Each treatment site was covered with Elastic adhesive dressing for a four hours period. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occulsive dressing and gauze pad were removed and the treatment site was washed with warm water (30-40°C) to remove any residual test substace. The treated area was blotted dry with absorbent paper.

All animals were observed daily for signs of ill health or toxicity.
Examination of the treated skin was made on Day 1 (i.e. approx 30 minutes after removal of the dressings) and on Days 2, 3, 4 (equivalent to 24, 48 and 72 hours).

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema 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:

no erythema or oedema observed in any animal at any observation stage.

Other effects:

no clinical signs observed

Interpretation of results:

GHS criteria not met

Remarks:

Not skin irritating

Conclusions:

A study was performed to assess the skin irritation potentialof CPTX. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for a maximum of four days. No reactions were observed following a single semi-occlusive application of CPTX to intact rabbit skin for four hours.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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)

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

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.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vivo skin irritation (Huntingdon 1991)

A study was performed to assess the skin irritation potentialof CPTX. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for a maximum of four days. No reactions were observed following a single semi-occlusive application of CPTX to intact rabbit skin for four hours.

 

In vivo eye irritation study (1991)

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.

 

Justification for classification or non-classification

Based on the available data, no classification for irritation is required for 1-chlor-4-(n-propoxy)-5-thioxanthen-10-one according to the Regulation EC n°1272/2008.