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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:
January 17, 1989 - January 24, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Version / remarks:
1981
Deviations:
yes
Remarks:
(occlusive treatment)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
EC Number:
406-940-1
EC Name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
Cas Number:
126019-82-7
Molecular formula:
C30-54H47-87O3PS
IUPAC Name:
O-2-(2-methylnonyl)phenyl O-4-(2-methylnonyl)phenyl O-2-(2-methyloctyl)phenyl phosphorothioate
Details on test material:
- Physical state: viscous liquid, insoluble in water; pH 7
- Storage condition of test material: room temperature
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 wks
- Weight at study initiation: 2230 - 2530 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet (Nafag No. 814), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d
- OTHER: All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972).

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the other flank of the same animal (treated with water)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL of undiluted test article
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 12-16 cm² (flanks)
- % coverage: at least 10
- Type of wrap if used: aluminium foil held in place with adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)

REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 4 h

SCORING SYSTEM: according to the OECD draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Other effects:
At the reading 72 hours the application site of 2 animals appeared somewhat dry and slight scaling was observed. A slight loss of weight was observed in 1 animal on day 3 (considered not to be treatment-related).

Any other information on results incl. tables

Bodyweights (g):

animal #1: (day 1) 2430; (day 3) 2430; (day 7) 2640

animal #2: (day 1) 2530; (day 3) 2530; (day 7) 2680

animal #3: (day 1) 2230; (day 3) 2200; (day 7) 2280

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In an acute dermal irritation/corrosion study following OECD guideline 404 and in compliance with GLP, three rabbits were exposed to 0.5 mL of the test substance for four hours. The test substance was applied onto the shaved flanks of the animals using an occlusive dressing. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Erythema and edema reactions were caused by the treatment, reversible within 7 days the latest. Because the mean values of the recordings 24 to 72 hours after application are below the threshold of significance, the test article can be classified as non-irritant.