Iron sulphide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to GLP and valid methods, therefore it is considered relevant, reliable and adequate for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 24 april 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Iron sulphide

EC Number:

215-268-6

EC Name:

Iron sulphide

Cas Number:

1317-37-9

Molecular formula:

FeS

IUPAC Name:

sulfanylideneiron

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore 560 058, India
- Age at treatment: 6-7 months
- Weight at treatment: 2.83 – 2.94 kg
- Fasting period before study: Not provided
- Housing: Individually in rabbit cages (approx. size L 65 x B 65 x H 45 cm) with noryl shallow cage body and facilities for pelleted food (Stainless steel feed hopper: changed at least 1x/week). The litter collection tray (noryl waste tray) will be changed daily (except on Sundays).
- Diet (e.g. ad libitum): Rabbit feed manufactured by Pranav agro Industries Ltd., Sangli, Maharashtra, India, ad libitum.
- Water (e.g. ad libitum): 750 mL makrolon bottle fitted with stainless steel sipper tube (changed at least 1x/week), deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India
- Acclimation period: One rabbit (RB9615) was acclimatized for 5 days while the other two (RB9616 and RB9617) rabbits were acclimatized for 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 65-67%
- Air changes (per hr): 12-15/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: July 19, 2012 To: July 28, 2012

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: de-ionised water

Controls:

other:

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 mL of
de-ionised water

Duration of treatment / exposure:

4 hours

Observation period:

At 1, 24, 48, 72 hours, 7 and 14 days post removal of test patch.
If reversibility is seen at 72 hours, 7 days or before 14 days, the experiment is terminated.

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: left side of the dorsolateral trunk
- % coverage: 6 cm2
- Type of wrap if used: cotton gauze (±6 cm : 2 x3 cm -6 ply) secured by an adhesive tape (‘Johnson –plast’ USP manufactured by Johnson & Johnson Ltd., Mumbai, India) and a crepe bandage around the torso

REMOVAL OF TEST SUBSTANCE
- Washing (if done): thoroughly with de-ionised water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the numerical scoring system of Draize et al. (1944)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Table 1. Individual Skin Reaction Scores

Rabbit No.	Sex	Washing after (hours)	observations for skin reactions (post removal of the test patch)	Erythema score		Edema Score		Total score
				C	T	C	T	C	T
RB9615*	M	4	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
RB9616	M	4	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
RB9617	M	4	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0

  M: Male;          C: Control patch;                   T: Treatment patch;                          0: No Erythema/No Edema 

 * : The responses (skin reactions) were assessed immediately after the removal of the test patches at 3 minutes, 1 hour and 4 hours after application and it indicated that the test item was not irritating or corrosive.

 

 

Table 2. Mean Skin Reaction Scores

Observation (post removal of the test patch in)	Erythema Score		Edema Score		Total Mean Score
	C	T	C	T	C	T
1 hour	0	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

C: Control patch;                            T: Treatment patch;                         0: No Erythema/No Edema

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results, the test item, Tribotecc®-Ferrostar is “Non-irritant” to the skin of New Zealand White Rabbits under the testing conditions adopted as per Draize’s Classification Scheme.

Executive summary:

The acute dermal irritation/corrosion study in New Zealand White Rabbits was conducted to evaluate the skin irritation potential of iron sulfide (Tribotecc ®-Ferrostar). A quantity of 0.5 g of the test item was made into paste by adding 0.2 mL of de-ionised water on a cotton gauze of 6 cm² applied to the prepared area of skin under occlusive dressing. After 4 hours contact period, the treated area was washed with de-ionised water. The study was conducted in a stepwise manner (i.e., one rabbit was dosed, followed by two additional rabbits). The degree of irritation was evaluated and scored by CLP classification method at 1, 24, 48 and 72 hours post removal of the test patch. The total mean score of skin reaction was ‘0’ at all the observation periods, indicating that the test item did not cause dermal irritation to rabbits. There were no toxic signs, pre-terminal deaths and no skin reactions observed. There were no abnormalities detected at necropsy.