Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Type of study / information:
A study consisting of a single 24-hour application using an occluded patch was conducted to evaluate the potential to cause irritation. Two evaluations were made; one 30 minutes after patch removal and the second at 24 hours post-patch removal. Two control were also tested; a positive irritant control and a negative control.
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A single 24-hour exposure was used.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
EC Number:
271-090-9
EC Name:
1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
Cas Number:
68515-48-0
Molecular formula:
C26 H42 O4
IUPAC Name:
Not available, not a single isomer
Constituent 2
Reference substance name:
DINP
IUPAC Name:
DINP
Details on test material:
- Name of test material (as cited in study report): MRD 95-140
- Substance type: liquid
- Analytical purity: assumed 100 %

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
Health male and female volunteers were entered into the study. Each test patch received 0.1 – 0.3 ml of the assigned test article. The final quantity dispensed is dependent upon the nature of the test material. Each subject will receive a single 24 +/- 1 hour contact application to specific skin sites of the paraspinal region of the back. All applications and patch removal will be conducted by a technician at the laboratory. Sites are scored at 30 minutes post-patch removal and 24 hours post-patch removal. Scoring of irritation was conducted by an experienced technical staff member using a 0-3 grade scoring scale for erythema and edema (3 being the most severe).
Exposure assessment:
not specified
Details on exposure:
TYPE OF EXPOSURE:
Occluded patch

EXPOSURE LEVELS:
0.3-0.5 ml

EXPOSURE PERIOD:
24 hours

POSTEXPOSURE PERIOD:
24 hours

Results and discussion

Results:
The group mean score for irritation was 0.00

Applicant's summary and conclusion

Conclusions:
Not irritating.
Executive summary:

MRD 95-140 (CAS 68515-48-0) was applied undiluted (0.2 ml) for 24 hours to human volunteers (fourteen female and one male subject) using an occluded patch applied to specific skin sites of the paraspinal region of the back, and was followed by an observation period of 24 hours. Two controls were also tested: a positive irritant control of 0.5% sodium lauryl sulphate in distilled water and a negative control of 0.89% NaCl in distilled water. No responses were observed. Mild to moderate erythema was observed with the positive irritant control at the 30-minute or 24 hour evaluation.