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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 10 July 1978 to 11 August 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted Human Repeated Insult Patch Test (HRIPT)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human Repeated Insult Patch Test (HRIPT)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide
EC Number:
223-829-1
EC Name:
2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide
Cas Number:
4090-51-1
Molecular formula:
C10H20O5P2S2
IUPAC Name:
2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 54
- Sex: both
- Age: >/= 18 years
- Demographic information: local population
Clinical history:
- History of allergy or casuistics for study subject or populations: no skin diseases, negative history of medical status for any illnesses which may rise to lesions which may erroneously be attributed to the test material
Controls:
no
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application:
induction: about 2 x 2 cm; on left upper arm; occlusive for 24 h each
challenge: on the 2nd Monday after the last exposure on previously unexposed sites, 24 h
- Concentrations: 60% aqueous paste
- Volume applied: approx. 0.1 g/cm2
- Testing/scoring schedule: induction: week 1, 2 and 3: Monday, Tuesday, Wednesday, Thursday; scoring after removal of test substance; on the 2nd Monday after the last exposure, scoring after removal of the test substance (15 min and daily thereafter)
- Removal of test substance: after 24 h


EXAMINATIONS
- Grading/Scoring system: 0: no visible irritation; +/-: very slight edema (questionable); 1+: erythema confined to the contact side, barely exceeding that of untreated skin; 2+: erythema confined to the contact side, definitely exceeding that of untreated skin; 3+: erythema exceeding that of untreated skin, with some edema, both confined to the contact side; 4+: erythema and edema, with one ore more complications such as: extension beyond margins of contact area, vesiculation and ulceration.
- Statistical analysis: not stated

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no effects visible at any time point

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study the test substance was not sensitising.
Executive summary:

The test substance was applied as 60% paste in a concentration of 0.1 g/cm2 to the left upper arm of 54 volunteers. Following a 24 h exposure the contact areas were evaluated. The test persons were exposed 12 times within three weeks. Challenge was performed on previously unexposed sites on day 11 after the last exposure. No signs of irritation or other skin effects were observable during the induction and the challenge phase. Therefore under the conditions of this study the test substance was not sensitising.