Reaction mass of aluminium chloride, iron dichloride, magnesium chloride and manganese dichloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study was conducted between 5th March 2004 and April 27th 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Iron (II) chloride

Molecular formula:

FeCl2

IUPAC Name:

Iron (II) chloride

Details on test material:

Name: Iron dichloride (¿)(CAS No.7758-94-3)
Lot No.: 23828CB
Accepted quantity: 25 g, 1bottle
Purity: 98%
Appearance: Pale brown powder
Storage conditions: Brown bottle, Dry place, Sealed

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
Company name: Samtaco Bio Korea
Location: 77-1 Seorang-dong, Osan-si, Gyeonggido (TEL: [phone]~8)
- Age at study initiation: 3 months old
- Weight at study initiation: 1600~1800 g
- Housing: animals were kept individually in stainless steel cages (600x500x300 mm, manufactured by Jeongdo Industrial).
- Diet (e.g. ad libitum): The animals were fed rabbit food (Purina Korea located in 85-1 Jangdang-dong, Pyeongtaek, Gyeonggido) . The contamination of the feed was checked with the analysis material provided by the feed supplier.
- Water (e.g. ad libitum): The animals freely drank water that was sterilized with UV. Water quality was tested in the Korea Testing & Research Institute. There was no pollutant in the water that would affect the test.
- Acclimation period: Not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2¿
- Humidity (%): 50±10%
- Air changes (per hr): 10~15
- Photoperiod (hrs dark / hrs light): Light-On for 12 hours (08:00~20:00)/Light-off for 12 hours,
Illumination intensity: 200~300Lux

IN-LIFE DATES: From: To:

Test system

Type of coverage:

other: not stated

Preparation of test site:

shaved

Vehicle:

other: Test material was moistened with distilled water

Controls:

other: Sites on the same animal were used for control purposes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the powder was finely ground and moistened with distilled water.
- Concentration (if solution): 0.5 g of the powder was moistened with distilled water.

VEHICLE
The test material was moistened with distilled water.

Duration of treatment / exposure:

In the first animal, one patch was removed after 3 minutes, the second patch was removed after 1 hour and the third patch was removed after 4 hours. 2 other rabbots were tested and these had an exposure duration of 4 hours.

Observation period:

Clinical sign observation:
Changes of clinical signs, poisoning and mortality were observed for 14 days after the application.

Body weight and foods/Water consumption measurement:
The animals weighed when they were accepted, and when the test started and ended. Consumption of food and water was not measured.

Observation of applied regions
In the initial test, the subjects were exposed to the test substance for three minutes, one hour and four hours and presence of irritations such as erythema, crust, and edema was observed at 0, 24, 48 and 72 hours after the patch removal. In the confirmative test, the subject was exposed to the test substance for four hours and was observed for skin irritations for 14 days at 24, 48, and 72 hours after the patch was removed.

Necropsy:
If an animal was in dead or critical condition after the application, necropsy was performed. Any organ, tissue or skin, which was found grossly abnormal, was fixed in 10% neutral formalin solution and histopathological examination was conducted.

Number of animals:

3 male rabbits.

Details on study design:

TEST SITE
- Area of exposure: 2 cm x 3 cm
- % coverage: not stated in report
- Type of wrap if used: non irritant wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the applied spot was gently rinsed with sterilized sodium chloride (Daihan Pharm located at 736-1, Wonsi-dong, Ansan, Gyeonggido).
- Time after start of exposure: not stated

SCORING SYSTEM:
Skin Response evaluation:
Erythema and crust formation
0 No erythema at all
1 Slight erythema (Barely identified with naked eyes)
2 Clear erythema
3 Moderate to severe erythema
4 Severe erythema (Scarlet redness) to crust formation that prevents evaluation of erythema
Total score

Edema
0 No edema at all
1 Very slight edema (Barely identified with naked eyes)
2 Slight edema (clearly swollen, so the marginal zone is clearly distinguished)
3 Moderate edema (swelling about 1 mm high)
4 Severe edema (Swelling more than 1 mm high and extending beyond the exposed spot)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritant / corrosive response data:

Observation of applied region:
Very slight edema was observed in the initial test after being exposed for one hour and four hours. In the confirmative test, two rabbits showed very slight edema after being exposed for four hours. The edema observed disappeared 24 hours after the patch was removed.

Other effects:

Clinical signs and mortality:
Excepting pale brown pigmentation of skin during the test period, no abnormality caused by the test substance was observed and no mortality occurred in all the animals.

Histopathological examination
Two lesions were found in the dermis of the rabbit used for the initial test. Hemorrhage and hemosiderosis were observed and small amounts of neutrophils and eosinophils, and lots of lymphocytes were found to be infiltrated. Light lymphocyte infiltration was observed in the dermis of the rabbit (Animal No. 2) used for the confirmative test

Body weight changes:
All the animals except one showed higher body weight at Day 14 (the last day of the test) than Day 0 (Group separation date).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The study was conducted according to the OECD guidelines, no effects were noted for either edema or erythema. The substance is not classified according to the Dangerous Substances Directive or CLP.

Executive summary:

After the test substance was applied to three New Zealand White male rabbits to study the skin irritation of iron dichloride, clinical signs, poisoning, mortality and body weight changes were observed for 14 days after the application and topical irritation was evaluated at the end of being exposed to the substance, after removal of patch, at 60 minutes, 24 hours, 48 hours and 72 hours after patch removal as follows.

 

a.      No mortality caused by the test substance was observed during the test period.

 

b.      No abnormalities were observed in the animals during this study.

 

c.      Normal body weight increases were observed in all the animals.

 

d.      As a result of observing topical irritation after being exposed to the test substance, edema was observed in all the animals at 1 hour and 4 hours after the application.

 

The study was conducted according to the OECD guidelines, no effects were noted for either edema or erythema. The substance is not classified according to the Dangerous Substances Directive or CLP.