Diiron tris(sulphate)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

26 March 2004 to 04 June 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 1

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Reference 2

Reference Type:

secondary source

Title:

Iron Dichloride CAS N°: 7758-94-3. SIDS Initial Assessment Report for SIAM 19 (Berlin, Germany, 19-22 October).

Author:

OECD Organisation for Economic Co-operation and Development

Year:

2004

Bibliographic source:

United Nations Environment Programme (UNEP) Publications, Nairobi, Kenya. 89 p. URL http://www.chem.unep.ch/irptc/sids/OECDSIDS/7758943.pdf

Reference 3

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report for SIAM 24 (Paris, France, 17-20 April).

Author:

OECD Organisation for Economic Co-operation and Development

Year:

2007

Bibliographic source:

Self-published, Paris, France. 138 p.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

U.S. EPA Good Laboratory Practice Standards, Toxic Substances Control Act (TSCA), 40 CFR Part 792, OECD Principles of Good Labortaory Practice (as revised 1997), ENV/MC/CHEM (98) 17 and NIER Public notice No. 1998-41, under Toxic Chemicals Control Act.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

iron dichloride anhydrous

IUPAC Name:

iron dichloride anhydrous

Constituent 2

Reference substance name:

Iron dichloride

EC Number:

231-843-4

EC Name:

Iron dichloride

Cas Number:

7758-94-3

Molecular formula:

FeCl2

IUPAC Name:

iron(2+) dichloride

Details on test material:

Identity: Iron dichloride (CAS No.: 7758-94-3)
lot number: 23828CB
Purity: 98%
storage conditions: Room temperature
Appearance: Tan powder
Stability: Stable

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Orient co. Ltd., Korea
- Age at study initiation: Approximately 8 weeks of age
- Weight at study initiation: 256.9 - 279.7 for males, 223.8 - 233.5 g for females
- Fasting period before study: not stated in report
- Housing: Individually housed in stainless steel cages with wire mesh floors
- Diet: ad libitum access to a certified rodent diet (2014, Lot 0206043MA, Teklad Global 14% Protein Rodent diet, Harlan Teklad, USA)
- Water: ad lbitum access to filtered/UV-treated tap water
- Acclimation period: seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 - 24.5°C during acclimation, 18.6 - 25.3°C during study
- Humidity (%): 35.0 - 69.4% during acclimation, 42.1 - 74.4% during study
- Air changes (per hr): not stated in report
- Photoperiod (hrs dark / hrs light): Lighting controlled automatically to provide 12 hours of artificial light (08:00 - 20:00 hours, 150 - 300 Lux) in each 24 hours period.

IN-LIFE DATES: From: Experimental phase initiation March 9th 2004 To: Experimental phase completion June 3rd 2004

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal flank
- % coverage: 10% of total body surface
- Type of wrap if used: Porous gauze dressing secured with a non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article removed using distilled water at end of the exposure period
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): Test article moistened with corn oil
- Concentration (if solution): not stated in report
- Lot/batch no. (if required): 122K0131
- Purity: not stated in report

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Checked at least once daily for mortality. Individually observed during first 4 hours after dosing and then daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - changes in skin and fur, eyes and mucous membrane and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern recorded at each observation.
Body weight - recorded on Day 1 (prior to dosing), day 8 and Day 15 (prior to necropsy).

Statistics:

No statistical analysis was performed because of the small sample size and absence of controls.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks:

FeCl2

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 881 mg/kg bw

Based on:

element

Remarks:

Fe

Effect levels 3

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks:

FeCl2

Effect levels 4

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

881 mg/kg bw

Based on:

element

Remarks:

Fe

Mortality:

There were no unscheduled deaths during the study.

Clinical signs:

other: Yellowish-brown change on the skin at application site observed in all treated animals from Day 2, but fully reversed by Day 15 except for 3 females. Two males and 4 females had reddish nasal discharge on Day 2.

Gross pathology:

No abnormalities observed during macroscopic examination. At the site of application, scarring was observed in one male and one female.

Other findings:

- Organ weights: not recorded
- Histopathology: not recorded
- Potential target organs: none
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test article to rats by a single dermal administration was considered to be greater than 2000 mg/kg bw under the conditions of this study. Therefore the substance (iron dichloride) is not classified for Acute dermal toxicity.

Executive summary:

This study was performed (using OECD Guideline No. 402) to assess the acute toxicity of the test article, iron dichloride (CAS No.: 7758 -94 -3) by single dermal administration to Sprague-Dawley rats. Mortality, clinical signs and bodyweight changes were monitored throughout the study. All animals were humanely killed as scheduled and examined macroscopically on Day 15, the end of the observation period.

Five female and five male rats each received 2000 mg/kg bw as a limit test. Because there was no mortality observed, the study was completed.

There were no unscheduled deaths and bodyweight gains were normal during the study.

A yellowish-brown change was observed at the application site in all test animals, and was considered to relate to the colour of the test article. Two males and 4 females had a reddish nasal discharge on Day 2, which was considered a distress symptom caused by pressure of taping on the thorax area.

During macroscopic examination, scarring was observed at the application site on one male and one female. This was considered to relate to application of the test article. internally, no abnormalities were observed.

In conclusion, the LD50 to rats of the test article, iron dichloride (CAS no.: 7758 -94 -3) by a single dermal administration is considered to be greater than 2000 mg/kg bw under the conditions of this study. Therefore the substance (iron dichloride) is not classified for Acute dermal toxicity.