Registration Dossier

Diss Factsheets

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:
07 May 1980 - 16 May 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets the basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
BASF-Test
Principles of method if other than guideline:
Method: BASF-Test. See further details in remarks on material and methods.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylaminoethanol
EC Number:
203-710-0
EC Name:
2-methylaminoethanol
Cas Number:
109-83-1
Molecular formula:
C3H9NO
IUPAC Name:
2-(methylamino)ethanol
Details on test material:
- Name of test material (as cited in study report): Methylethanolamin
- Physical state: colorless liquid
- Analytical purity: 99 %
- Impurities (identity and concentrations): water: 0.5 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: M. Gaukler, Offenbach, Germany
- Weight at study initiation: 3.5 kg (mean)
- Diet: Ssniff K, standard diet for rabbits and guinea pigs, supplied by INTERMAST GmbH, Soest, Germany, ad libitum.
- Water: tap water ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
3 min, 1h or 4 h
Observation period:
8 days
Number of animals:
4 h application: 1 male and 1 female
1 h application: 2 females
3 min appliction: 2 males
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 3 min, 1 h or 4 h.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
; 3 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
1.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
; 3 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
erythema score
Remarks:
; 1 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
; 1 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
2.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
erythema score
Remarks:
; 4 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
; irreversible necrosis
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
; 4 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks:
; irreversible necrosis
Remarks on result:
other: 72 h reading is missing

Any other information on results incl. tables

Mean erythema score after 24 and 48 (72 h reading is missing); (animal1/animal2)

   24 h  48 h  72 h  mean  
 3 min  1/2 1/1  -/-  1/1.5  
1 h   4/4 4/4   -/-  4/4  
 4 h  4/4 4/4 -/-   4/4  

Mean edema score after 24 and 48 (72 h reading is missing); (animal1/animal2)

   24 h  48 h 72 h  mean  
 3 min  0/2  0/0  -/-  0/1  
 1 h  2/3  2/2  -/-  2/2.5  
 4 h  3/2  2/2  -/-  2.5/2  

3 min exposure: 24 h after application slight erythema was observed and 1 animal showed distinct edema. At the end of the observation period of 8 days the irritations eased under scaling.

 

1 h exposure: immediately after exposure wide spanning erythema and distinct spanning edema were observed. After 24 h parchment-like necrosis was noted. At the end of the observation period of 8 days, persistent edema and leathery-like necrosis was observed. This is considered to be a full thickness necrosis.

 

4 h exposure: immediately after exposure necrosis and wide spanning edema was noted. At the end of the observation period of 8 days irreversible necrosis was observed. This is considered to be a full thickness necrosis.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test substance is corrosive
Executive summary:

Test substance is corrosive