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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptably documented study report.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sample ref: 46-350, 47-116. No further information

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped fur. Intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
3 days. Observations scored at 5hrs, 1, 2 and 3 days
Number of animals:
3 male, 3 female
Details on study design:
TEST SITE
- Dose appplied to clipped, intact skin under a guaze patch that is loosely covered with impervious sheeting. Animals restrained during exposure. Excess removed after exposure period.

SCORING SYSTEM: Draize, measurements at 1hr, 1, 2, 3, days. Also 7, 10 and 14 days if required.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Irritant / corrosive response data:
Irritation scores were 0 for both erythema and odema at all observation times.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance has no skin irritation potential.
Executive summary:

In a skin irritation study that complies with the main requirements of the appropriate OECD guideline, six rabbits were used to assess the skin irritancy of 2 -(2 -methoxyethoxy)ethanol. None of the animals showed any response indicative of irritation. The substance does not need to be classified as irritant in the EU.