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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-12-17 to Feb 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Remarks:
GLP declaration included in full study report.

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenothiazine
EC Number:
202-196-5
EC Name:
Phenothiazine
Cas Number:
92-84-2
Molecular formula:
C12H9NS
IUPAC Name:
10H-phenothiazine
Details on test material:
- Label: CA 794
- Appearance: pale yellow coloured crystalline solid
- Date of arrival: 28 November 1986
- Storage conditions: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK
- Weight at start of study: 2.36 - 2.48 kg
- Age at start of study: 12 - 16 weeks
- Identification: Ear mark and cage label
- Acclimatisation: min 5 days
- Housing: individually in suspended metal cases
- Diet: Rabbit Diet, Preston Farmers Ltd, New Leake, Boston, Lincolnshire, UK, ad libitum
- Water: drinking water, ad libitum
- Room temperature: 17 - 21°C
- Relative humidity: 45 - 50 %
- Air exchange rate: approx. 15 per hour
- Lighting: 12 hours light / 12 hours darkness

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- 0.5 g of the test material moistend with 0.5 ml of distilled water.
Duration of treatment / exposure:
4 hours
Observation period:
One hour, 24, 48 and 72 hours after removal of the patch.
Number of animals:
3
Details on study design:
- Area of exposure: 2.5 x 2.5 cm
- Type of patch: gauze patch

- Removal of residual test material four hours after application.
- Removal of residual test material by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM:
According to Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, TX, "The Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics".

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No data
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, CA 794, was found to be a non-irritant to rabbit skin according to the EEC labelling regulations and requires no symbol or risk phrase.
Executive summary:

Summary

The potential for skin irritation/corrosion of the test substance was investigated by applying the test substance to the skin of 3 New Zealad White rabbits.

No evidence of skin irritation was noted during the study period.

The test material, CA 794, was found to be a non-irritant to rabbit skin according to the EEC labelling regulations and requires no symbol or risk phrase.