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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from supporting substance. Guideline study to GLP.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Manston Road, Margate, Kent, UK
- Age at study initiation: young adult
- Weight at study initiation: 2933 g (f)
- Fasting period before study: not applicable
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: not available

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg (test substance as supplied, 69.1% A.I. containing 26.2% water)
Duration of treatment / exposure:
1 h
Observation period:
3 days
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not stated
- Type of wrap if used: surgical gauze covered by rubber sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 1 hour

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: mean of animal 1
Remarks:
Individual scores not specified in the report
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Remarks on result:
other:
Remarks:
Max. duration: 72 d; Max. value at end of observation period: 3
Irritation parameter:
edema score
Basis:
animal: mean of animal 1
Remarks:
Individual scores not specified in the report
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Remarks on result:
other:
Remarks:
Max. duration: 72 d; Max. value at end of observation period: 4
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 3 days
Other effects:
No irritation was seen at the skin site exposed to the test
material for 3 minutes.


Following exposure to the test material for 1 hour there
were significant erythema and oedema reactions. Additional
observations included blanching and a wrinkling of the
application site both of which were considered evidence of a
possible necrotic reaction. Histopathology confirmed a
pronounced inflammatory reaction consisting of severe
epidermal necrosis and inflammation along with slight dermal
oedema and slight hair follicle loss.

Any other information on results incl. tables

Additional observations included blanching, suspected necrosis, application sites raised and wrinkling of the application site. As a result of suspected necrosis at day three, a sample of skin from the test site and a control sample was sent for histopathological examination.Histopathology confirmed a pronounced inflammatory reaction consisting of severe epidermal necrosis and inflammation along with slight dermal oedema and slight hair follicle loss in the test section examined.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
ITC 826 Concentrate is concluded to be corrosive to rabbit skin following a one-hour application.
Executive summary:

A sample of ITC 826 Concentrate was assessed for its skin irritation potential. On the basis of an in vitro pre-screen the experiment was designed to assess irritation/corrosivity in a single animal following a three minute and one hour exposure. The animal was assessed for up to three days for any signs of irritation/corrosivity.

No irritation was seen at the three minute application site.

At the one hour application site, very slight to severe erythema and slight to severe oedema was observed. Additional observations included blanching, suspected necrosis, application sites raised and wrinkling of the application site. As a result of suspected necrosis at day three, a sample of skin from the test site and a control sample was sent for histopathological examination.

Histopathology confirmed a pronounced inflammatory reaction consisting of severe epidermal necrosis and inflammation along with slight dermal oedema and slight hair follicle loss in the test section examined.

On the basis of these data, ITC 186 Concentrate is considered to be corrosive to rabbit skin following a one hour application.