Neodecanoic acid, iron salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Iron Dichloride

Author:

OECD

Year:

2004

Bibliographic source:

SIDS Initial Assessment Report For SIAM 19 (Berlin Germany, 19-22 October 2004)

Reference 2

Reference Type:

other: secondary source

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Iron dichloride

EC Number:

231-843-4

EC Name:

Iron dichloride

Cas Number:

7758-94-3

Molecular formula:

Cl2Fe

IUPAC Name:

iron(2+) dichloride

Specific details on test material used for the study:

- Name of the test material: Iron dichloride
- Purity: 98 %,
- Source and Lot No.: Sigma-Aldrich, Lot No.: 23828CB

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Age of test animals: 8 weeks
- Body weight of test animals during the study: 256.9 – 279.7 g for males and 223.8 – 233.5 g for females

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

- Preparation of test substance: In this study, test article was weighed and wetted with corn oil (CS149, Sigma, Lot No. 122K0131).

- Administration of the test article: Animals were clipped their fur on dorsal part approximately 10 % of the total body surface area one day before dosing. The test article was applied uniformly and held in contact with the skin with a porous gauze dressing and non-irritating tape for 24-hour exposure period. At the end of the exposure period, residual test article was removed using distilled water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Clinical observations:
Cages of rats were checked at least once a day for any mortality. Animals were individually observed hourly during the first 4 hours after dosing with special attention, and daily for a total of 14 days. The nature and severity of the clinical signs and time were recorded at each observation.

- Body weights:
The body weight of each rat was recorded on day 1 (prior to dosing), day 8 and day 15 (prior to necropsy). Individual body weight changes were calculated.

- Necropsy:
All animals were killed on Day 15 by carbon dioxide asphyxiation and subjected to gross necropsy consisted of opening the thoracic and abnormal cavities. All gross pathological changes were recorded for each animal.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

During the study, there was no unscheduled death.

Clinical signs:

other: Yellowish-brown change on the skin of applied site was observed in all treated animals from day 2 but this sign was recorvered on day 15 except 3 animals. 2 males and 4 females showed the reddish nasal discharge on day 2.

Gross pathology:

Internally, no abnormalities were observed in all animals by microscopic examination. On application sites, scars were observed in one male and one female.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results, the LD50 value was determined to be greater than 2000 mg/kg bw. Thus, the substance does not have to be classified according to CLP regulation 1272/2008.

Executive summary:

In an acute dermal toxicity study conducted according to OECD guideline 402, groups of Sprague-Dawley rats (5/sex) were treated dermally for 24 hours with 2000 mg/kg bw iron dichloride (98.5% purity). No mortality occurred during the 14-day observation period. Yellowish-brown changes on the skin of applied sites were observed in all treated animals from day 2 but this was recovered during the test period, except for 3 females. 2 males and 4 females showed reddish nasal discharge on day 2. All rats gained normal body weight throughout the study. Regarding gross pathology, no abnormalities were observed in all animals. Only in one male and in one female, scars were observed on the application sites. Based on the results, the dermal LD50 can be considered to be greater than 2000 mg/kg bw.