2-methylaminoethanol

Acute Toxicity: dermal

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

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

Test material information

Constituent 1

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)ethan-1-ol

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 or test system 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:

other: 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. Afte

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:

GHS criteria not met

Conclusions:

If administered dermally in rats, MMEA caused systemic toxicity. Even though the study results reveal that the criteria for classification and labelling according to EU-GHS are not met, the substance still has to be classified and labelled for Acute Tox derm. Cat 4 due to an existing leally binding harmonised Classifcation.

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.