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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:
1975-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(evalutation after 48 hours is missing; occlusive dressing; test substance was applied as a 50 % solution of which 1 mL/test site was used; exposure period of 24 hours)
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Didodecyl 3,3'-thiodipropionate
EC Number:
204-614-1
EC Name:
Didodecyl 3,3'-thiodipropionate
Cas Number:
123-28-4
Molecular formula:
C30H58O4S
IUPAC Name:
didodecyl 3,3'-sulfanediyldipropanoate
Details on test material:
- Name of test material (as cited in study report): IRGANOX PS 800
- Physical state: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.3 kg (males) and 2.98 kg (females)
- Housing: individually
- Diet: commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: sterile filtered, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved with and without abrasion
Vehicle:
other: polyethylene glycol
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL/test site
- Concentration (if solution): 50 % (w/v) in polyethylene glycol
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 10 % of the total body surface
- Type of wrap if used: The test substance was applied to each test site on a 2.5x2.5 cm² gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24 and 72 hours
Score:
0.09
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24 and 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin site
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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