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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:
11January - 22 March 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, fully OECD 404 compliant, except for the use of weanling pigs rather than rabbit. The weanling pig skin is more predictive for irritative and corrosive effects to human skin than rabbit skin.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Weanling pig instead of rabbit; first reading immediately after patch removal rather than at 60 min; observation period 7 days instead 14 when all lesions were judged to be resolving and reversible in nature.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Organic
- Physical state: opaque paste
- Analytical purity: 97.8% (CoA)
- Composition of test material, percentage of components:
- Tertiary amine (mw 350) : 97.8%
- Primary amine (mw 262) + Secundary amine (mw 306): 2.0 %
- Moisture: 0.1%
- Purity test date: 24 Oct 2001
- Lot/batch No.: 257314 (Lotnr: SR257314X)
- Expiration date of the lot/batch: not indicated
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
pig
Strain:
other: Domestic swine, Yorkshire/Landrace cross
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Eisterhold Farm, Poseyville, IN, USA
- Age at study initiation: appeox. 6 weeks (weanling)
- Weight at study initiation: 10-11.4 kg
- Housing: Pigs were housed individually in adjacent run (approximately 3 X 6 ft) with chain link wire sides and epoxy coated floors.A nominal anount of hard wood chips for bedding (heat treated and contaminant free) was put on the floor. A plastic ball was put in each run for the animal's well being and behavioral needs.
- Diet : A commercially available pig feed was provided twice daily in sufficient quantity to maintain weight and condition. No dietary analysis was conducted.
- Water: ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 26.1 (69-79°F)
- Humidity (%): 30
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 Jan To: 28 Jan 2002

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
prior to dosing, 4 hours (after removal of test substance), 24, 48, 72, 6, 120, 144 and 168 hours post dose (moment of
determination of reversibility of effects)
Number of animals:
3 animals: 2 males, 1 female
Details on study design:
TEST SITE
- Back of pigs were shaved for approx. 8 x 12 inch; In total 4 different chemicals were tested simultaneously.
- Area of exposure: approx. 6 cm2
- Type of wrap if used: The test sites were covered with the gauze, secured by tape, then wrapped with a selfadhering bandage (CoflexTM) during the dosing period. The pigs were not restrained during the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes: Wrap was removed any residual test article was removed using a paper towel moistened with water. Care was taken to avoid altering the existing response and the integrity of the epidermis.
- Time after start of exposure: removal after 4 hours exposure

SCORING SYSTEM: According to Draize (1959) for erythema and eschar formation and oedema. In addition, each site was scored for necrosis, exfoliation, hair loss, and scab and scar formation. Each site was graded and photographed.






Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.78
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The erythema and edema observed on the test sites after dosing followed by the scabbing and exfoliation are expected sequela to
the application of a dermal irritant. The reduction of erythema and edema by 168 hours (7 days) postdose, and the exfoliation of the scab/epidermis revealing healthy underlying skin are evidence of skin healing and the apparent reversibility of the skin lesions.
No observations were made during this study that could be defined as corrosive in nature (i.e. necrosis, ulceration, cracking,
bleeding etc.).
Other effects:
No mortality and clinical signs.
Body weights show normal gain at an expected rate.

Any other information on results incl. tables

Summary of dermal irritation (following 4-h application)

Animal no.

Effect

Hour

Days after application

Mean score erythema

(24/48/72 h)

Mean score oedema

(24/48/72 h)

0*

1

2

3

4

5

6

7

BWJ 1M01

Erythema

Oedema

0

0

2

2

2

2

2

0

1

0

1

0

1

0

1

0

2.0

1.33

BWJ 1F01

Erythema

Oedema

0

0

1

1

2

1

2

0

1

0

1

0

1

0

1

0

1.67

0.67

BWJ 1F02

Erythema

Oedema

0

0

1

2

2

1

2

0

1

0

1

0

1

0

1

0

1.67

1.00

Mean all animals

1.78

1.00

* Immediately after patch removal

Summary of dermal lesions (following 4-h application)

Animal no.

Effect

Hour

Days after application

0*

1

2

3

4

5

6

7

BWJ 1M01

Scab

Exfoliation

0

0

0

0

1

0

1

0

2

0

1

2

1

2

1

2

BWJ 1F01

Scab

Exfoliation

0

0

0

0

1

0

1

0

1

0

1

1

1

1

0

1

BWJ 1F02

Scab

Exfoliation

0

0

0

0

1

0

1

0

1

0

1

0

1

0

1

0

Mean all animals

* Immediately after patch removal

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Armostat 310 can be classified as mildly irritating to the skin.
Executive summary:

The irritation/corrosion potential of Armostat 310 was evaluated following the principles of OECD guideline 404 (adopted 17.07.1992)

0.5 g of the pure test material was applied to the skin of three domestic swine for four hours. Parameters for evaluation included body weights at initiation and study termination, daily observations for mortality and clinical signs of toxicity, and dermal scores recorded pretest and at 4, 24, 48, 72, 96, 120, 144, and 168 hours (7 days) post-dose.

No mortality or clinical signs of toxicity were observed during the 168-hour observation period.

Scab formation was observed on all three animals beginning at the 48 hour observation period and extending to the 168 hour observation period (slight/moderate scabbing). Exfoliation (slight/moderate) was observed on two of the three animals beginning at the 120 hour observation period extending to the 168 hour observation period.

Based on this study, Armostat 310 can be classified as a mild irritant to the skin (Category 3 according to OECD-GHS).