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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 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: in accordance qith guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ALGIFERT K+
- Substance type: Dried alkaline extract of marine algae Ascophyllum nodosum dissolved in aqueous solution
- Physical state: Solid, black, micro- flakes, characteristic odour
- Analytical purity: not applicable
- Lot/batch No.: 32325-020509
- Expiry date: 02 May 2012
- Supplier: Valagro S.p.A. (sponsor)
- Storage condition of test material: the Test Article was stored in its original container, as supplied by the Sponsor at room temperature in the Test Article Stores of INTOX. The stability of the test substance in storage will be the responsibility of the Sponsor.
- pH: 9.2 (1% aqueous solution)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Serum Institute of India Ltd., Pune.
- Age at study initiation: Young adults (6 to 7 months)
- Weight at study initiation: 2.44 to 2.63 kg
- Housing: Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
- Diet (e.g. ad libitum): 'Amrut' brand extruded pelleted rabbit feed manufactured by Pranav Agro Ltd., Pune, provided ad libitum.
- Water (e.g. ad libitum): Potable water, passed through AquaGuard™ water filter, and subjected to ultra violet irradiation, provided ad libitum in stainless steel bowls, throughout the acclimation and study period.
- Acclimation period: The animals were acclimated for six days in the experimental room before start of the experiment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23oC
- Humidity (%): 30-70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.

IN-LIFE DATES: From: 10 September 2009 To: 17 September 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
Millipore Elix-10 system analytical grade
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the patch removal.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsolateral trunk
- % coverage: about 12-20 cm2 on the back between the scapular and the lumbar region
- Type of wrap if used: gauze bandage was wrapped around the animal and secured with tape to keep the test article in contact with the skin without undue pressure

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 3 minutes (patch 1), 1 hour (patch 2) and 4 hours (patch 3)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0

Any other information on results incl. tables

INDIVIDUAL ANIMAL CLINICAL SIGNS

Animal

ID.

Clinical Signs as Observed on Day

1

2

3

4

RB7831

NAD

NAD

NAD

NAD

 

RB7832

NAD

NAD

NAD

NAD

 

RB7833

NAD

NAD

NAD

NAD

 

NAD - No abnormality detected       

Day 1 is the day of application

INITIAL TEST ON ONE ANIMAL

Animal ID.

Sex

Application Site / Patch

Exposure Period

Observations1

E

Oe

RB7831

Male

Patch 1

3 minutes

0

0

Patch 2

1 hour

0

0

Patch 3

4 hours

0

0

1Made immediately after patch removal

CONFIRMATORY TEST

Animal ID.

Sex

Observation Time*

1 h

24 h

48 h

72h

E

Oe

E

Oe

E

Oe

E

Oe

RB7831

Male

0

0

0

0

0

0

0

0

RB7832

Male

0

0

0

0

0

0

0

0

RB7833

Male

0

0

0

0

0

0

0

0

Total

0

0

0

  0

0

0

0

0

Mean Score :

 (E + Oe) / 3

0

0

0

0

Primary Irritancy Index (highest mean score)                 : 0.00

Clarification of Irritancy as per Draize (1959)                 : Non-irritant

0: No Erythema/Oedema              * Time after patch removal                           E - Erythema                                Oe – Oedema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on the ‘primary irritation index’ of 0.00 observed in this study, and as defined in the criteria for evaluation, ALGIFERT K+ is classified as a Non-irritant to skin of rabbit.
Executive summary:

Testing of ALGIFERT K+ for its acute irritation / corrosion potential in the rabbit skin was performed in compliance with the Organization for Economic Cooperation and Development (OECD) Guidelines for Testing of Chemicals, Section 4,404 - Acute Dermal Irritation / Corrosion study, adopted 24th April 2002. This test was performed in accordance with the sequential testing strategy recommended in this OECD Test Guideline. Three test patches were applied sequentially to the animal tested in theinitialin vivotest. The first patch was removed after three minutes. Because no skin reaction was observed a second patch was applied at a different site and removed after one hour. As the observations at this stage indicated that exposure could be humanely allowed to extend to four hours, a third patch was applied and removed after four hours, and the response was graded. The response observed in the initial test was confirmed using two additional animals, each with one patch, for an exposure period of four hours. The test article in the amount ofwas pulverised andmoistened withwaterand appliedon to the clipped intact dorsal skin of the rabbits and the test site was covered with a gauze patch (approx. 6 cm2). At end of the designated exposure period of four hours, the patches were removed and skin reaction was evaluated immediately (initial test) and after 1, 24, 48 and 72 hours. Skin reaction scores were allotted according to the OECD test guideline. Animals were observed for abnormal clinical signs throughout the Test period. Body weights were recorded on the day of treatment and at the termination of the study.

During the initial single animal and confirmatory tests, ALGIFERT K+ did not cause any skin reaction, as observed at 1, 24, 48 and 72 hours after the patch removal. The primary irritancy indexdetermined from the scores of the skin reactionswas observed to be Zero (0.00).

Based on the ‘primary irritation index’of 0.00 observedin this study, and as defined in the criteria for evaluation,ALGIFERT K+is classified asaNon-irritantto skin of rabbit.