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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1963-09-30 to 1964-02-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Qualifier:
according to guideline
Guideline:
other: Draize AH (1959). Appraisal of the safety of chemicals in food, drugs and cosmetics, The Association of Food and Drug Officials of the United States, p52
GLP compliance:
no
Remarks:
study predates GLP
Type of study:
other: Human repeat insult patch test (HRIPT)
Justification for non-LLNA method:
LLNA not available at time of testing
Specific details on test material used for the study:
- Name of test material (as cited in study report): Sample SC-1431-A
- Substance type: Odorous liquid
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
SUBJECTS
- Age and sex distribution:
-- Male 16-20 yrs: 1
-- Male 31-40 yrs: 2
-- Male 41-50 yrs: 6
-- Female 21-30 yrs: 1
-- Female 31-40 yrs: 10
-- Female 41-50 yrs: 16
-- Female 51-60 yrs: 1
Route:
epicutaneous, semiocclusive
Vehicle:
other: Ethanol
Concentration / amount:
5 %
Route:
epicutaneous, semiocclusive
Vehicle:
other: Ethanol
Concentration / amount:
5 %
No. of animals per dose:
43 subjects started programme, 37 completed.
Details on study design:
INDUCTION APPLICATIONS
- Test patch was a 1 in square patch of Webril (absorbent non-woven cotton fabric) affixed to the centre of a 1 × 3 in strip of adhesive elastic bandage material.
- Immediately before application to the subject, 0.5 mL of sample was added to the Webril swatch and the bandage was then placed on the subject's upper arm.
- 6 to 9 different samples were tested simultaneously on each group of subjects, and the order of application rotated from one subject to the next.
- The subjects removed the test bandages after 24 hrs.
- Series of 9 × 24 hr exposures on a Mon-Wed-Fri sequence for 3 wks.
- The reaction to each exposure scored at the following session. Reaction to the 9th exposure on Mon of wk 4.
- Test patch applied to same site each time, except if reaction to sample or adhesive tape rendered this inadvisable, in which case the test patch was omitted or applied to a fresh site.

- Deviations: Closed patches were applied to subject #77 for the first 3 applications, and subjects #103 and #112 for the first two. Thereafter, regular semi-open patches were used.

CHALLENGE APPLICATION
- On Mon of wk 6 a challenge patch was applied to a site not previously exposed and removed after 24 hrs.
- Reactions to the challenge were scored on Wed and Fri of wk 6.
- (Minor departures from the schedule were necessary).

PRELIMINARY TEST
- Initially 10 subjects started on each sample.
- If no untoward effects were observed upon completion of these, approx. 30 subjects were added to the test group.
- Occasionally subjects failed to complete the test for reasons irrelevant to the purpose of the study. In all cases subjects exhibited no significant differences in reactions from other subjects in the group during the time that they were under observation.

SCORING SYSTEM
- Subjects scored on scale of 1-6 as follows:
-- 0: No evidence of irritation
-- 1: Slight erythema
-- 2: Marked erythema
-- 3: Erythema and papules
-- E: Erythema and oedema
-- 4: Very strong oedema and/or papules
-- 5: Vascular eruption
-- 6: Grade E or stronger reaction extending well beyond area of contact.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
No. with + reactions:
0
Total no. in group:
37
Clinical observations:
Little or no primary irritation was caused by the test sample.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 37.0. Clinical observations: Little or no primary irritation was caused by the test sample..
Reading:
2nd reading
Hours after challenge:
96
Group:
test chemical
No. with + reactions:
0
Total no. in group:
37
Clinical observations:
Little or no primary irritation was caused by the test sample.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 37.0. Clinical observations: Little or no primary irritation was caused by the test sample..

None of the 37 subjects was sensitised by the sample.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for skin sensitisation using a human repeat insult patch test. Under the conditions of the test, the test substance was not sensitising.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test material was found to be non-sensitising in a Human Repeat Insult Patch Test (HRIPT), and this has been used as a key study. Supporting studies from 3 week fixed dose, Draize test, and guinea pig maximisation test (GPMT) support this finding. However, one positive result has been discounted which was an intradermal FCAT study.


Migrated from Short description of key information:
The test material was found to be non-sensitising in a Human Repeat Insult Patch Test (HRIPT), and this has been used as a key study. Supporting studies from 3 week fixed dose, Draize test, and guinea pig maximisation test (GPMT) support this finding. However, one positive result has been discounted which was an intradermal FCAT study.

Justification for selection of skin sensitisation endpoint:
A valid study is available for the target substance, Decanal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. Further studies on Decanal were used to support the key study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A valid study is available for the target substance, Decanal. The study meets generally accepted scientific standards with acceptable restrictions for the standard test. Further studies on Decanal were used to support the key study.

The test material was found to be non-sensitising in a Human Repeat Insult Patch Test (HRIPT), and this has been used as a key study. Supporting studies from 3 week fixed dose, Draize test, and guinea pig maximisation test (GPMT) support this finding.