Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 March 1992 to 13 April 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
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 the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dipotassium heptafluorotantalate
EC Number:
240-986-1
EC Name:
Dipotassium heptafluorotantalate
Cas Number:
16924-00-8
Molecular formula:
F7Ta.2K
IUPAC Name:
Tantalate(2-), heptafluoro-, potassium (1:2)
Test material form:
solid: crystalline
Details on test material:
- Name of test material : Di-Kaliumtantalfuorotantalate (Kaliumtantalflourid)
- Molecular formula: K2TaF7
- Physical state: White Crystals
- Storage condition of test material: Within a closed drum, protected against humidity.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Supplier Thomae Biberach
- Weight at study initiation: 2.97 kg ± 0.052
- Housing: Individually in steel wire cages
- Diet: Altromin K, Type 2023, pasteurised laboratory small animal diet, ad libitum.
- Water: ad libitum mains supply.
- Acclimation period: Minimum of 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20ºC ± 2 ºC
- Humidity: 40 -60-%
- Air changes: 12-15 times/hour
- Photoperiod: 12 hrs light, 12 hours dark.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2mL
Duration of treatment / exposure:
4 hours
Observation period:
0.5, 1, 4, 6, 24, 48, and 72 hours and day 6.
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: On the day prior to application hair was shaved from an area approximately 30 cm x 20 cm on the dorsal trunk. 0.5g of the test substance was placed on a 6 cm² gauze patch and moistened with 0.2ml of water. The patch was positioned on the right side of the dorsal midline.
- Type of wrap if used: 6cm² gauze was secured to the test area with Leukoplast.

REMOVAL OF TEST MATERIAL
- Washing: At the end of the exposure period the dressing was removed and gently washed away with water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: The Draize scale (Draize 1959, presented as table 1 in the field "Any other information on materials and methods incl. tables") was used to asses the degree of erythema and oedema at the application sites 0.5, 1, 4, 6, 24, 48, and 72 hours and 6 days after the exposure period prior to necropsy.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 6 days
Score:
0
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
Neither erythema or oedema were detected during the observation period according to the Draize scale.
Other effects:
A slight to barely perceptible whitish appearance was detected after patch removal, which was shed in the following days. Through microscopic findings this was interpreted as a slight dehydration of the surface layers of the skin. Results are presented in table 2 in the field " any other information on results incl. tables".

There were no other signs of ill-health in any animal during the study.

Any other information on results incl. tables

Table 2: Clinical Observations

Key:

N - normal behaviour

W - slightly whitish coloured skin (treated area)

(W) - barely perceptible whitish coloured skin (treated area)

 Animal No., Sex  1M  2M  3M  4M  5M  6M
day 0   N  NW  N  N  N  N
day 1  N (W)  NW  N  N (W)  N  N
day 2  N  N (W)  N  N  N  N
day 3  N  N  N  N  N  N
day 4  N  N  N  N  N  N
day 5  N  N  N  N  N  N
 day 6  N  N  N  N  N  N

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material did not evoke any reaction in any of the test animals. Therefore the test material does not require classification as a skin irritant.
Executive summary:

The skin irritation of the test material was determined in accordance with the standardised guidelines EPA OPP 81-5 (Acute Dermal Irritation). Six rabbits received a single application of 0.5g of the test material for four hours and were assessed for the following 6 days for any sign of skin irritation. Neither erythema or oedema were seen in any of the tests animals over the observation period. Only a slight dehydration of the skin was observed in the test area which subsequently disappeared in the following days after patch removal. There were no other signs of skin irritation.

Under the conditions of the study, the test material is considered to be non-irritating to the skin.