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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate
EC Number:
274-011-6
EC Name:
Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate
Cas Number:
69452-87-5
Molecular formula:
C30H57O7PS3
Test material form:
liquid
Details on test material:
Generic name: TGE - Phosphite

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 weeks
- Weight at study initiation: 2100-2490 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland; ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3° C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
three females
Details on study design:
TEST SITE
- Area of exposure: at least 6 sq. cm
- Type of wrap if used: A gauze patch bearing 0.5 ml of the test substance was applied to the skin and looseli held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg)

OBSERVATION TIME POINTS
- 1, 24, 48 72 hours

SCORING SYSTEM:
- Method of calculation: per guidelines

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.5
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: minimal irritation
Remarks:
see attached table of results
Irritant / corrosive response data:
Grade 2 erythema and Grade 1 oedema was observed in one animal at 1 hour. This animal showed Grade 1 erythema and Grade 1 oedema at 24 hours. A second animal showed Grade 1 erythema at 1 hour. No reactions were seen in the third animal.
Other effects:
The animals showed a normal body weight development.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP Criteria
Conclusions:
In a guideline (OECD 404) in vivo skin irritation study, TGE Phosphite was found to be a non-irritant to intact rabbit skin. The calculated dermal irritation index was 0.5. All reactions cleared within 48 hours.