Registration Dossier

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:
2003-05-13 to 2003-05-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD 404; US EPA , OPPTS 870.2500; EU Method B.4 and JMAFF, Japanese test guideline without deviations.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The testing facilty indicated that the protocol was followed without deviation.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The testing facilty indicated that the protocol was followed without deviation.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Remarks:
The testing facilty indicated that the protocol was followed without deviation.
Qualifier:
according to
Guideline:
other: JMAFF , Japanese guideline
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: HC1161
- Substance type: pure active substance
- Physical state: colourless-white solid
- Analytical purity: not indicate by sponsor, treated as 100 % pure
- Expiration date of the lot/batch: 2003-07-31
- Stability under test conditions: stable under storage condition
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors
- Diet: approx. 100 g standard laboratory rabbit diet per day, pressed hay twice a week
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 22.5 deg C
- Humidity (%): 38 - 77 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours artificial fluorescent light per day


IN-LIFE DATES: From: 2003-05-13 To:2003-05-30

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not treated skin of treated animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
4hr
Observation period:
at 1, 24 48, 72 hrs
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area free of fur (150 square centimeters)
- % coverage: no data
- Type of wrap if used: metalline patch of 2x3 cm


REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4hr


SCORING SYSTEM:
Eyrthema and eschar formation:
0 No erythem
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to sever erythema
4 Severe erythema (beet redness)
Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (=4) is given.

Oedema formation:
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (raised approximately 1 millimeter)
4 Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
312 (sentinel)
Time point:
other: 1 hr
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
312 (sentinel)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
338
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: After 1 hour the same observations were made.
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
348
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: After 1 hour the same observations were made.
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
312 (sentinel)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: After 1 hour the same observations were made.
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
338
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: After 1 hour the same observations were made.
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
348
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: After 1 hour the same observations were made.
Irritant / corrosive response data:
-Irritation: at 4 h exposure to 0.5 g of HC1161 resulted in very slight erythema in treated skin-area of 1/4 rabbit, which had resolved within 24 hours after exposure (see Remarks on results").
-Corrosion: There was no evidence of a corrosive effect on the skin.
Other effects:
-Colouration: No staining of the treated skin by the test substance was observed.
-Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Any other information on results incl. tables

Table: Individual Skin Irritation Scores

Animal #

312 (sentinel)

338

348

Time after exposure

Erythema

Oedema

comments

Erythema

Oedema

comments

Erythema

Oedema

comments

1 hour

1

0

-

0

0

-

0

0

-

24 hours

0

0

-

0

0

-

0

0

-

48 hours

0

0

-

0

0

-

0

0

-

72 hours

0

0

-

0

0

-

0

0

-

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information 1 rabbit reversible (within 24 h) slight irritation (after 4 h exposure) Criteria used for interpretation of results: other: EU GHS
Conclusions:
According to EC criteria for classification and labelling the HC1161 does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

The study was conducted in compliance with the OECD Guideline 404 and GLP.

The objective of this primary skin irritation study was to assess the irritation potential of a single dose of the test substance administered to the intact skin of rabbits.

Three rabbits were exposed to 0.5 gramm of HC1161, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observation were made 1, 24, 48 and 72 hours after axposure.

No skin irritation was observed after exposure. The test material is not irriating to the skin.