Hematite (Fe2O3)

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29.04.94 to 20.07.94

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an/the appropriate OECD test guideline, and in compliance with GLP. The study is read across from ferrous sulfate.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle
- Age at study initiation:No data
- Weight at study initiation: 2.6 ±0.1kg
- Housing: Individually in polystyrene cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±3
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 25.05.94 To: 21.06.94

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): 500mg
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Up to four hours (1 minutes and 1 hour in one animal each and 4 hours in 3 animals)

Observation period:

Observations at 1, 24, 48  and 72 hours after removal of the dressing and then daily until day 14 in order to observe their reversibility.

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: Flank
- % coverage: No data, area of 6cm2
- Type of wrap if used: Semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test substance was removed by means of a dry compress.


SCORING SYSTEM: The interpretation of results was carried out according to the classification criteria laid down in directive 93/21/EEC Commission Directive of 27th  April 1993 adapting to technical progress for the eighteenth time Council Directive 67/548/EEC.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Very slight or well-defined cutaneous reactions were observed after application of the test substance during 3 minutes and 1 hour. Severe cutaneous
reactions were observed after application of the test substance during 4 hours. No necrosis or ulceration of the skin was observed. All lesions were reversible before the end of the 14-day observation period.

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information FeSO4.7H2O Criteria used for interpretation of results: EU

Conclusions:

In a well conducted and documented skin irritation study (reliability score 1) conducted to OECD 404 and GLP, ferrous sulfate was irritating to the skin of two of three New Zealand white rabbits, and it was therefore concluded that this substance is irritating to the skin.

Executive summary:

In a well conducted and documented skin irritation study (reliability score 1) conducted to OECD 404 and GLP, a single dose of 500 mg ferrous sulfate (moistened with water) was applied to the clipped skin (6cm2 on flank) of three male New Zealand white rabbits. The test substance was held in contact with the skin by means of a semi-occlusive dressing for four hours. Cutaneous reactions were recorded at 1, 24, 48 and 72 hours after removal of the dressing, and then daily until day 14 in order to observe the reversibility of the reactions. Residual test substance was removed by means of a dry compress. The mean score for erythema and oedema were recorded for each animal using 24, 48 and 72 hours values. Very slight or well-defined cutaneous reactions were observed after application of the test substance during 3 minutes and 1 hour. Severe cutaneous reactions were observed after application of the test substance during 4 hours. No necrosis or ulceration of the skin was observed. All lesions were reversible before the end of the 14-day observation period. It was concluded that ferrous sulfate was irritating to the skin.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Species: SPF bred New Zealand White albino rabbits
Supplier: Charles River Wiga, Sulzfeld, Germany
Sex and age: males or females, young adult
Date of arrival: October 15, 1993
Transferred to test room: December 7, 1993
Date of dosing: December 13, 1993
Acclimatization period: 6 days
Body weight range at start of study: 2969-3557 g
Identification: earmarking: 636-641
Caging: individually in suspended galvanized cages, fitted with wire-mesh floor and front
Diet: standard laboratory rabbit diet and tap water, ad libitum

ENVIRONMENTAL CONDITIONS
Lighting: 12 hours light/12 hours dark cycle
Temperature (7/12-20/12/93): 20 ±3°C
Humidity (7/12-20/12/93): 47.5-72.5%
Ventilation: ca. 10 air changes/hour

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: vaseline

Controls:

no

Amount / concentration applied:

0.5 g test substance mixed with 0.5 g vaseline

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

6

Details on study design:

Four days prior to the start of the study, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. One day and just prior to application of the test material, the skin site was inspected for hair growth. If needed, the clipping was repeated. The study was carried out with six rabbits and each rabbit was treated as follows:
A plastic cup with a diameter of ca 2.5 cm was loaded with ca 1.0 g of the test mixture (0.5 g of the test material and 0.5 g vaseline). Next, a skin site suitable for application of the test substance was selected on the clipped area on the back of the animal. The cup was placed on an intact skin site and fixed to the application site by means of adhesive tape. The entire trunk of the rabbit was wrapped with a self-adhesive-gauze to maintain the cup in position. The gauze was additionally fastened with two strips of tape. After an exposure period of 4 hours, the cup and the material applied were removed. Next, the application site was cleaned with a paper tissue and water, and ca 1 hour later, the resulting skin reactions were evaluated by the method of Draize et al.. Further skin readings were made at approximately 24, 48 and 72 hours, and at 7 days after treatment. The primary irritation index (PII) was calculated by dividing the sum of all skin scores obtained by the number of animals (6) multiplied by the number of observations (4).

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hr

Score:

0.8

Max. score:

4

Remarks on result:

other: mean, 6 animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean, 6 animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean, 6 animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean, 6 animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hr

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean, all animals, all timepoints

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

4

Remarks on result:

other: mean, 6 animals

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean, 6 animals

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean, 6 animals

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean, 6 animals

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hr

Score:

1.57

Max. score:

4

Remarks on result:

other: mean, all animals, all timepoints

Irritant / corrosive response data:

The report notes that skin reactions present in 5 of the 6 treated rabbits extended “over a large skin area outside the application site”, however this is not further characterized.
Dermal responses were initially quite mild and consisted of very slight erythema (no oedema) in 5 of 6 animals 1 hr after patch removal.
At 24 hours, moderate to severe erythema (grade 3) and slight oedema (grade 2) was present in all animals.
At 48 hours, moderate to severe erythema was present in 4 of 6 animals with well defined erythema present in the remaining 2 animals; very slight (3/6) or slight (3/6) oedema as also observed.
At 72 hours, moderate to severe erythema was present in 3 of 6 rabbits, with well defined (2/6) or very slight (1/6) erythema affecting the remainder; slight (3/6) or very slight (1/6) oedema was also present in 4 rabbits (resolved in others).
No dermal responses were present in any animal at observation day 7.
The results demonstrate that sulfur (50% in Vaseline) is irritating to rabbit skin following 4 hour semi-occluded contact. Irritation was absent at 1 hour after patch removal but showed a marked increase in intensity thereafter which was sustained to 72 hr.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Sulfur is irritating, but not corrosive, to rabbit skin.

Executive summary:

Sulfur was examined for acute dermal irritating/corrosive properties in an experiment with six albino NZW rabbits, in compliance with OECD guideline 404 and under GLP. The dermal exposure period was 4 hours under semi-occlusive conditions. Skin irritation scores were recorded using Draize criteria at 1, 24, 48 and 72 hours and at 7 days after removal of the test material. Irritation was initially absent, however 24 hr after patch removal moderate to severe erythema (grade 3) and slight oedema (grade 2) had developed in all animals, and was decreased only slightly at the 48 hr and 72 hr observation periods. Mean erythema and oedema scores of 2.67 and 1.57, respectively, were calculated for all animals taking into account responses at 24, 48 and 72 hr, however all skin effects had resolved completely by day 7.

On the basis of these results, it is concluded that sulfur is irritating, but not corrosive, to rabbit skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Pyrite cinder is an inorganic mineral substance with irritating properties towards eye and skin. 

 

Effects on skin irritation/corrosion: irritating

 

Effects on eye irritation: causes serious eye damage

 

 Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

In relation to the information available the UVCB substance is classified Skin irrit. 2; H315 (for its content of S, FeSO4 and CAO) and Eye Dam. 1; H318 (for its content of CAO)