Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 Nov 1979 - 23 Nov 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets 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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
BASF-Test
Principles of method if other than guideline:
BASF test. Further details in remarks on material and methods.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethylaethanolamin
- Analytical purity: 100 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Hagemann, Extertal, Germany
- Weight at study initiation: male: 267 g (mean); female: 185 g (mean)
- Diet: Herilan MRH-Kraftfutter (H. Eggersmann, Rinteln), ad libitum
- Water: tap water ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm2
- Type of wrap if used: inert foil.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was washed off with warm water and dried with cellulose.
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Frequency of weighing: day 0, 4, 7, 12
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured.
Clinical signs:
Systemic toxicity: Dyspnoea, apathy, staggering, salivation, cry of pain, poor general state.

Local irritation:
After 24 h soft anemic necrosis, severe edema, pea-size 3 mm deep ulcers.
After 7 days parchment-like necrosis, slight edema, wrinkles.
After 14 days leathery-like necrosis wrinkles partially open and weeping.
Body weight:
Initially the male animals lost slightly weight and the females only gained marginal weight (see details in table in remarks on results).
Gross pathology:
No abnormalities.

Any other information on results incl. tables

Weight (g):

 Dose (mg/kg bw)

 Gender  day 0  day 4  day 7  day 12    
 2000  male  267 262  288 311    
 2000  female  185 186 200 212    

No mortality occured during the 14 -day observation period in both sexes.

There is indication that the test substance causes local irritation to the exposed tissue.

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
If administered dermally in rats, MMEA caused systemic toxicity.
Executive summary:

The acute dermal toxicity of 2-methylaminoethanol was determined for White Vienna rabbits (BASF AG, 1981). For this purpose, the product was applied once for 24 hours to the clipped skin of the back and flank (area about 50 cm²) unchanged in a dose of 2000 mg/kg. The treated area of skin was then covered with an inert foil, which was secured in position with adhesive tape. The bandage was removed after an exposure period of 24 hours; subsequently, the test substance was washed off with warm water and dried with cellulose. The LD50was determined taking into account the DOT guidelines, but it was not established precisely.
No mortalities occurred during the study. Following signs of systemic toxicity were observed by treated animals: dyspnoea, apathy, staggering, salivation, cry of pain and poor general state. After 24 hours, soft anemic necrosis, severe edema, pea-size 3 mm deep ulcers appeared. After 7 days these ailments progressed to parchment-like necrosis, slight edema and wrinkles. After 14 days, leathery-like necrosis wrinkles partially open and weeping was still present in the treated animals. Gross pathology revealed no abnormalities.