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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Primary irritation patch test, 24h occlusive exposure on 19 human volunteers with dose finding test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous formulation
Details on test material:
- Name of test material (as cited in study report): BioTerge-AS-40
- Analytical purity: No data
- Physical state: clear liquid

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 19
- Sex: 1 male, 18 female
- Age: 18 to >60
Ethical approval:
not specified
Route of exposure:
dermal
Exposure assessment:
estimated
Details on exposure:
A Q-Chamber with Webrill disc was used for occlusive exposure of 2mL of 0.3, 1 and 3.0% of the test substance. Prior application of the test patches the pH of the test material was adjusted with citric acid to achieve a range of 6-7. The test patches were placed on the back of the subjects for 24h and the reactions were examined 1/2, 24 and 48h after patch removal.

Results and discussion

Clinical signs:
no data

Any other information on results incl. tables

Table 1: Reactions on the test substance

 

Subjects with positive reactions/tested subjects at

Concentration of test substance

½ h

24h

48h

0.3%

3/19

9/19

2/18

1.0%

6/19

13/19

4/18

3.0%

11/19

14/19

5/18

Based on the 1/2-hour and 48-hour scorings, BioTerge AS-40 was well tolerated at concentrations of 0.3% and 1.0 % but the 24-hour scorings were in contradiction and suggested that BioTerge AS-40 showed significant skin irritation at all doses.

Applicant's summary and conclusion