Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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 Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
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:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
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 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: March 9th 2004 To: 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

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths occurred at the limit dose level
Mortality:
There were no unscheduled deaths during the study.
Clinical signs:
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.
Body weight:
Normal bodyweight gain was exhibited by all rats throughout the study.
Gross pathology:
No abnormalities observed during macroscopic examination. At the site of application, scarring was observed in one male and one female.

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. By read-across the similar iron salt, iron trinitrate, is also 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 and by read-across, the similar salt, iron trinitrate, is also not classified for dermal toxicity