Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1992-06-01 to 1992-07-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study protocol was provided and was cited as adapted from the Draize test. Further, the results were well-documented and scientifically acceptable.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across source

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
There are no guidelines available for human subject testing and this study adapted from the Draize method.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Neodene 18 (WRC RIR-1174-T)
- Substance type: C18 alpha olefin

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 36
- Sex: Male and female
- Age: >18 years
Controls:
Sodium Laurly Sulphate (0.1 % w/v) in distilled water
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Semi-occlusive
- Vehicle / solvent: Mineral Oil
- Concentrations: 25% in mineral oil
- Volume applied: Not reported
-Testing schedule: Nine applications (24-hours each) were administered three/week over a 3-week period (induction phase), followed by a 10-15 day rest period, then a 24-hour application to both the original and a naïve site (challenge phase).

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: 24 hours


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 29
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 2 subjects exhibited mild erythema during induction

Applicant's summary and conclusion

Conclusions:
Neodene® 18 does not cause clinical irritation or sensitisation in human subjects.
Executive summary:

Neodene® 18 (25% in mineral oil) was tested for the potential to induce contact sensitisation upon repeated application under semi-occlusive conditions. Sodium lauryl sulfate (0.1% in distilled water) was used for comparison. The test conditions were appropriate for this study type. Reactions were scored with a numerical and letter grade to indicate severity and type of reaction. Only two of the thirty-one subjects exhibited mild erythema (which was resolved within 24 hours) during the induction phase compared to nine subjects exhibiting mild to moderate erythema after exposure to 0.1% sodium lauryl sulfate. Results indicate that Neodene® 18 does not cause clinical irritation or sensitization in human subjects.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study protocol was provided and was cited as adapted from the Draize test. Further, the results were well-documented and scientifically acceptable.