Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, study predating OECD guideline, but scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-morpholinoethanol
EC Number:
210-734-5
EC Name:
2-morpholinoethanol
Cas Number:
622-40-2
Molecular formula:
C6H13NO2
IUPAC Name:
2-(morpholin-4-yl)ethan-1-ol

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.0 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
1, 5, 15 min
20 h
Observation period:
8 days
Number of animals:
2 males
Details on study design:
TEST SITE
- Area of exposure: Back (2.5 x 2.5 cm) and ear

SCORING SYSTEM: Draize scoring system. Results originally reported according to BASF scoring system and transformed to scores according to OECD guideline 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: application time 20 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: application time 20 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: application time 20 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: application time 20 h
Irritant / corrosive response data:
No signs of irritation were observed in two animals after 1, 5 and 15 min exposure on the back. Slight redness was observed in both animals after 24 and 48 h (ear and back) when treated for 20 h. The irritation was reversible within 8 days.
Other effects:
none

Applicant's summary and conclusion

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