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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
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

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

Test system

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).

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.