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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-methyliminodiethanol
EC Number:
203-312-7
EC Name:
2,2'-methyliminodiethanol
Cas Number:
105-59-9
Molecular formula:
C5H13NO2
IUPAC Name:
2-[(2-hydroxyethyl)(methyl)amino]ethan-1-ol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 - 3.0 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Material was applied to the clipped dorsal trunk skin and maintained in occlusive contact for 24 h by gauze which was placed over the dose, covered with impervious polyethylene sheeting, and retained with VETRAP bandaging tape. Animals were examined for signs of toxic and/or pharmacologic effects daily and for local skin effects at 17 and 14 d after removal of the occlusive dressing. Animals were weighted before dosing and at days 7 and 14 post dosing. All animals were subjected to gross necropsy examination.

Clinical signs daily during the observation period (14 d).
- Local skin effects observations: 1 hr, 7 d, 14 d after removal of occlusive dressing.
- Gross pathological examinations on all animals.
- Body weights were recorded before dosing, and 7 and 14 d post dosing.
Statistics:
moving average method

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
10 244 mg/kg bw
95% CL:
>= 7 436 - <= 14 144
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
11 336 mg/kg bw
95% CL:
>= 9 339 - <= 13 822
Mortality:
- No. of deaths: not indicated.
- Time of death: 1 to 12 days after administration (males) and 3 to 11 days after administration (females)
Clinical signs:
Signs, which were few, included sluggishness, unsteady gait, emaciation and prostration, all of which developed by the end of the dosing period. Survivors usually recovered from these effects between 3 and 5 days after the start of dosing.
Body weight:
Animals lost weight during the first post dosing week, with partial recovery during the second week.

Gross pathology:
Necropsy of animals that died revealed dark red mottled lungs, dark red livers and mottled kidneys. Most survivors at necrospy did not reveal any gross pathology, but a few showed red mottled lungs and dark red livers.
Other findings:
erythema and oedema with ecchymosis, necrosis and ulceration was observed until the end of the observation period. During week 2 local desquamation, alopecia and scarring had developed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met