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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 August 1989 to 03 September 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
15336-18-2
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Ammonium hexachlororhodate
- Substance type: red-coloured powder
- Physical state: solid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: “Assay: 29.39%” [presumably percentage of rhodium].
- Lot/batch No.: S071559
- Expiration date of the lot/batch: no data
- Stability under test conditions: not determined
- Storage condition of test material: in a plastic flip-top jar at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: approximately 12-16 weeks
- Weight at study initiation: 2.52-2.70 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum “Rabbit Diet” from Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK
- Water (e.g. ad libitum): ad libitum mains drinking water
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 62-68 [relative]
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm [6.25 cm2]
- Type of wrap if used: material was placed under a gauze patch secured in place with a strip of surgical adhesive tape (BLENDERM, approximate size 2.5x4.0 cm). An elasticated corset (TUBIGRIP) was applied over this, around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (gentle swabbing with cotton wool soaked in distilled water)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Erythema and eschar formation, and oedema formation, were assessed approximately one, 24, 48 and 72 hours after removal of the patches. A primary irritation index was calculated by adding all of the 24- and 72-hour readings (scored using the Draize scale, see “Any other information”) and dividing by the total number of observations (i.e. six). According to the study report, a primary irritation index of zero indicates a “non-irritant”; one of >0-2 indicates a “mild irritant”; one of >2-5 indicates a moderate irritant and one of >5-8 indicates a severe irritant.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours after patch removal
Score:
0
Max. score:
8
Reversibility:
other: not applicable
Remarks on result:
other: see below
Irritant / corrosive response data:
No evidence of skin irritation. See attchment.

Yellow-orange staining of the skin caused by the test material was observed. Nevertheless, it was reported that this did not prevent accurate assessment of the skin responses, particularly erythema and eschar formation, for which scores of 0 for all rabbits at all time points were recorded. The study was terminated 72 hours after removal of the patches because of the lack of adverse skin reactions.
Other effects:
No other effects or systemic toxicity were reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline study, to GLP, ammonium hexachlororhodate produced a primary irritation index of 0 following a 4-hr semi-occlusive application (0.5 g) to the skin of three rabbits. No corrosive effects or evidence of systemic toxicity were reported.
Executive summary:

In an OECD Test Guideline 404 study, ammonium hexachlororhodate was investigated for irritant (and corrosive) effects following a 4-hr (semi-occluded) application (0.5 g) to the shaved, intact skin of three male White Russian rabbits. The test sites were quantitatively and qualitatively assessed for erythema (and eschar) formation and oedema 1, 24, 48 and 72 hrs after removal of the patches.

No erythema or eschar formation, or oedema, was seen at any time point in any animal. A primary dermal irritation index of 0 was calculated using the observations at 24 and 72 hr. Yellow-orange staining of the skin caused by the test material was observed. Nevertheless, it was reported that this did not prevent accurate assessment of the skin responses. No other effects or systemic toxicity were reported.

Based on the results of this study, no classification for skin irritation is required according to EU CLP criteria (EC 1272/2008).