Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF test
PROCEDURE
Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test).
White Vienna rabbits were used. Usually, 2 animals were treated for 5 minutes and for 2 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid or powdered and moistened test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal / lateral flank of the back.

After the application time, the skin was washed with water which sometimes contained a mild detergent.

The animals were observed 5 days and skin changes were recorded on working days.

The report usually describes findings after 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 hours and 5 days from the raw data have to be taken into account.
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methoxypropoxypropanol
- Physical state: liquid
- Substance number: 78/187
- Vapour pressure (20°C): 0.4 Torr

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 1 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Exposure times: 5 min and 2 hours
Observation period:
up to 5 days
Number of animals:
2 (1 male, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h, 48 h and 5 d
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h, 48 h and 5 d
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating