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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1988-09-19 to 1988-10-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions. This is an acceptable, well-documented study report that follows sound scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Primary Activation Phase: three sites on the back of each participant were chosen as potential contact sites: One for initial contact and two for alternative sites. Investigators were instructed to stop using the initial contact site when a response of Grade 4 or greater was obtained on that site.
Alternate site was used for the challenge phase.
GLP compliance:
yes
Remarks:
GLP applicable to the protection of the privleges and well-being of individuals who participate in patch test procedures.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: oily liquid
Details on test material:
- Name of test material (as cited in study report): MRD-88-289
- Substance type: Other Lubricant Base Oil, Sufficiently Refined (IP 346 <3%)
- Physical state: Brown viscous liquid

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 112 adult humans
- Sex: Male and Female
- Age: >18 years
- Known diseases: Subjects with known diseases were excluded from the study
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
0.2 mL of lubricating base oil was applied dermally under occlusive wrap during the first week and under semi-occlusive wrap thereafter. The participants were treated with lubricating base oil once a day, four days a week, for four weeks. A challenge phase was conducted where the participants were treated with 0.2 ML once a day, four days a week, for one week. Participants were asked to report any change in dermal effects for two weeks after the end of the challenge week. Irritation was scored following The International Contact Research Group System (3) and the Product Investigations, Inc. scoring method.

Results and discussion

Clinical signs:
There were no signs of clinical toxicity observed during the primary or challenge phase
Results of examinations:
Adverse changes which could be attributed to an irritating activity of the test material were observed in five subjects during the initial week and in eight subjects during the subsequent weeks of the Primary Phase. Faint to moderate erythema was observed in 8 of the 112 volunteers.

There were no clinically significant responses observed during the Challenge Phase.
Outcome of incidence:
The absence of any clinically significant responses during the challenge phase indicates that the test material does not possess a skin-sensitising propensity.

Applicant's summary and conclusion

Conclusions:
The test material did not produce more than a faint to moderate response in the skin of the 112 participants. It was concluded that because the conditions of the study would be more stressful than the exposure to a consumer, contact with the test material should be tolerable to the general population.
Executive summary:

In a primary dermal irritation study, 112 human adults were dermally exposed to 0.2 mL of Lubricant base oil (MRD-88 -289). The participants were treated with Lubricant base oil (MRD-88 -289) once a day, four days a week, for 13 exposures. A challenge phase was conducted where the participants were treated with 0.2 mL once a day, four days a week, for one week. Participants were asked to report any change in dermal effects for two weeks after the end of the challenge week. Irritation was scored following The International Contact Research Group System (3) and the Product Investigations, Inc scoring method.

In this study, Lubricant base oil (MRD 88 -289) was not a dermal sensitiser based on the small number of slight or mild irritation responses recorded.

This study received a Klimisch score of 2 and is classified as reliable with restriction.