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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restriction (pre-GLP study).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

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:
BASF-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyldiaethanolamin
- Analytical purity: 98 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.9 kg (mean)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin site of the same animal
Duration of treatment / exposure:
1, 5, 15 min and 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
Two animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5, 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 1, 5 and 15 min

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1, 5 and 15 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms
Irritation parameter:
edema score
Remarks:
1, 5 and 15 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Application of undiluted methyldiethanolamine to rabbit skin did not produce reactions after periods of 1 to 15 minutes but wide spanning reddening of the whole dorsal skin area and at the end of the observation period scale formation were reported in one animal after 20 hours contact with the substance.

Any other information on results incl. tables

Mean erythema score after 24, 48 h and 72 h (animal1/animal2):

   24 h  48 h  72 h  mean  
 1 min  0/0 0/0 0/0  0/0  
 5 min  0/0 0/0 0/0  0/0  
 15 min  0/0  0/0  0/0 0/0   
 20 h  3/2  3/2  3/2  3/2  

Mean edema score after 24, 48 h and 72 h (animal1/animal2):

   24 h  48 h  72 h  mean  
 1 min 0/0 0/0 0/0  0/0  
 5 min 0/0 0/0 0/0  0/0  
 15 min  0/0  0/0  0/0  0/0  
 20 h  3/0  3/0  2/0  3/0  

Application of undiluted methyldiethanolamine to rabbit skin did not produce reactions after periods of 1 to 15 minutes but wide spanning reddening of the whole dorsal skin area and at the end of the observation period scale formation were reported in one animal after 20 hours contact with the substance.

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information