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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb 14 - March 15, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 17, 1992
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyltriphenylphosphonium chloride
EC Number:
418-400-2
EC Name:
Methyltriphenylphosphonium chloride
Cas Number:
1031-15-8
Molecular formula:
C19H18ClP
IUPAC Name:
methyltriphenylphosphanium chloride

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Source:
Kaninchenhof Süstedt, Alter Pohl 8, 27305 Süstedt
Animal selection:
random
Animal identification:
with individual ear tags; cage labelled with ear tag no., sex, date of study initiation, project no.
Housing:
individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
Illumination:
artificial lighting (120 lux) from 7.00 a.m. -7.00 p.m.
Temperature:
20 +/- 3°C
Relative humidity:
30-70%
measurement:
twice daily

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
0,5 g powder of test item was moistured with 0.2 mL aqua ad iniectabilia to ensure a good contact with skin
Duration of treatment / exposure:
4 h
Observation period:
Animals were examined for signs of erythema and oedema at 60 min, 24, 48 and 72 h after patch removal and thereafter once daily up to day 15 p.a. Due to the absence from findings on the :first 3 days after patch removal the animal no. 1 was not involved in the observation on the days 4, 5 and 6. Skin reactions were evaluated according to the scheme presented on the next page.
Number of animals:
3
Details on study design:
24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was examined for abrasions and only animals with healthy, intact skin were used in the test. The powdery test article was moistened sufficiently with 0.2 ml aqua ad iniectabilia to ensure a good contact with the skin.
In each animal, 0.5 g of the test article were applied to the test site (ca. 6 cm2 in size), an adjacent area of untreated skin serving as a control. Each skin area was covered with a semi-occlusive dressing consisting of Ypsiplast@ (Holthaus Medical, Remscheid-Liittringhausen), which was held in place by non-irritating tape (Elastoplast@,Beiersdorf AG, Hamburg), and Stiilpa@(p. Hartmann AG, Heidenheim- Brenz), which enveloped the whole of the animal's trunk. The duration of exposure was 4h.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: #1-#3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight to well-defined redness and very slight to slight swelling were observed in all animals up to the end of the observation period: in animal no. 1 from day 7 p.a., in animal no. 2 from 24 h p.a. and in animal no. 3 from day 8 p.a. The observed findings were not reversible within 15 days after patch removal.
Other effects:
No other toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test for acute dermal irritation/corrosion according to OECD Guideline No. 404 was performed with the test item.
Under the conditions of the present study, a single dermal application of the test item to rabbits at a dose of 0.5 g produced redness and swelling in all animals. These findings were not reversible within 15 days after patch removal.
Executive summary:

The potential toxicity of the test item was assessed in an acute dermal irritation/corrosion test on 3 albino rabbits. The skin was exposed to the test article for 4 h. Animals were examined for signs of erythema and oedema at 60 min, 24, 48 and 72 h after patch removal and thereafter once daily up to day 15 after patch removal.

Redness and swelling were observedinall animals. These findings were not reversible within 15 days p.a. No other toxic effects were observed.