Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable study with limited information about test item.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Duhring-Kammer Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 5
- Known diseases: healthy
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
70 µl of the test item was applied on the upper arm (Large Finn chamber) and left theier for 24 h under occlusive conditions.Erythema and edema scores were noted after 1, 24, 48, 72 and 144 h after removal of test item.
Examinations:
Erythema, edema

Results and discussion

Clinical signs:
Only one volunteer showed erythema and edema. The reactions were located in the area of the patch but not where the test item was applied.

Applicant's summary and conclusion

Conclusions:
The test item is well-tolerated by human skin. No signs of irritation were observed.
Executive summary:

The toxic-irritative effect of the test item was investigated in the modified During-chamber test in five volunteers. No reactions were observed (erythema-edema). The test item is considered to be tolerated well on human skin.