Distillates (petroleum), hydrotreated heavy naphthenic

Direct observations: clinical cases, poisoning incidents and other

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

Test material information

Constituent 1

Reference substance name:

most likely 64742-52-5

IUPAC Name:

most likely 64742-52-5

Constituent 2

Reference substance name:

Severely Hydrotreated Heavy Naphthenic Distillate (Sufficiently Refined, IP 346 <3%)

IUPAC Name:

Severely Hydrotreated Heavy Naphthenic Distillate (Sufficiently Refined, IP 346 <3%)

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.