Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Copper iodide.
- Analytical purity: 99.7%
- Lot/batch No.: 108701/2 REACH STANDARD 290911
- Storage condition of test material: room temperature in the dark.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: Eight to twelve weeks.
- Weight at study initiation: Males 226 - 242 grams. Females 200 - 214 grams.
- Fasting period before study: None.
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-Hour exposure period and in groups of up to four, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C.
- Humidity (%): 30 to 70%.
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- % coverage: Approximately 10% of the total body surface area.
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-Hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg.
- For solids, paste formed: No. The appropriate amount of test item, moistened with arachis oil BP, was applied as evenly as possible to an area of shorn skin.
Duration of exposure:
24 hours.
Doses:
In the absence of data suggesting the test item wastoxic, one male and one female rat were initially treated with the test item at a doselevel of 2000 mg/kg. As no mortalities were noted a further group of animals (four males and four females) was similarly treated with the test item at a dose level of 2000 mg/kg to give a total of five males and five females.
No. of animals per sex per dose:
Five males, five females.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: The animals were observed for deaths or overt signsof toxicity ½, 1, 2 and 4 hours after
dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: Yes.
- Other examinations performed: clinical signs, body weight. After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to Draize. Any other skin reactions, if present were also recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Very slight erythema was noted at the test sites of all animals.

Any other information on results incl. tables

The following tables are attached:

Table 1: Individual dermal reactions - males.

Table 2: Individual dermal reactions - females.

Table 3: Individual bodyweights and weekly bodyweight changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Copper iodide is not classified on the basis of dermal toxicity.
Executive summary:

A GLP-compliant study was performed to assess the acute dermal toxicity of copper iodide in the Wistar strain rat. The method was designed to be compatible with OECD Guideline 402 and EU Method B3. Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths and no signs of systemic toxicity. Very slight erythema was noted at the test sites of all animals. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of copper iodide in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. The test item is not classified on the basis of dermal toxicity.