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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
2-aminoethanol
EC Number:
205-483-3
EC Name:
2-aminoethanol
Cas Number:
141-43-5
IUPAC Name:
2-aminoethanol
Details on test material:
- Name of test material: Monoethanolamine (2-Aminoethanol)
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
1.0, 2.0 or 4.0 mL/kg bw
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for toxicity and skin reactions were made at 1 hour, 7 days and 14 days after the contact period. Animal weights were recorded at 0 (before dose), 7 and 14 days (just prior to termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopical examination

Groups of 5 animals/sex (2-3 kg) were subjected to 24 hours of contact with the test item (1.0, 2.0 or 4.0 mL/kg bw) which was retained under impervious sheeting on the clipped, intact skin of the trunk. As necessary for larger doses, gauze was wrapped around the trunk over the sample to prevent leakage. Bandaging tape was wrapped over the impervious sheeting and the animal was returned to its cage for the contact period. Doses were varied by adjusting the volume of the test material. After the contact period, excess fluid was removed to diminish ingestion. At death or termination, each animal was subjected to a gross pathologic evaluation.
Statistics:
LD50 values and the estimated LD50 slopes were calculated by the moving average method (Thompson, 1947; Weil, 1983).

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2.46 - <= 2.83 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
2 504 mg/kg bw
95% CL:
1 822 - 3 451
Remarks on result:
other: slope: 5.60
Sex:
female
Dose descriptor:
LD50
Effect level:
2 881 mg/kg bw
95% CL:
1 639 - 5 070
Remarks on result:
other: slope: 3.89
Mortality:
The mortality incidences were as follows:
4.0 mL/kg bw: 9/10 rabbits (5 males, 4 females; at 1-2 days)
2.0 mL/kg bw: 2/10 rabbts (1 male, 1 female; at 2 days, at 13 days)
1.0 mL/kg bw: 0/10 rabbits (0 male, 0 female; N/A)
Deaths occurred within two days, except for one female rabbit that died at 13 days.
Clinical signs:
MALES
4.0 mL/kg bw
erythema, edema, necrosis, ecchymosis at 1 day; prostration in 1 animal at 1 day
2.0 mL/kg bw
erythema, edema at 1-7 days, or death; necrosis at 1-14 days, or death; ecchymosis at 1 day, persisting on 1 animal to ulceration at 7 or 14 days; desquamation, alopecia on 1 animal at 14 days; scabs at 14 days; sluggishness at 1 or 7 days; emaciation of 1 animal at 7 days; recovery of 2 survivors after 2 days

1.0 mL/kg bw
erythema at 1 day; persisting on 1-7 days; edema at 1-7 days; ecchymosis on 1 animal at 1 day; necrosis at 1-14 days; scabs, ulceration at 7-14 days; no signs of systemic toxicity

FEMALES
4.0 mL/kg bw
erythema, edema, ecchymosis at 1 day to death; necrosis at 1 day to death, persisting on 1-14 days; scabs, ulcerations on 1 animal at 7-14 days; sluggishness at 1 day; recovery of 1 animal at 2 days

2.0 mL/kg bw
erythema, edema at 1-7 days; necrosis at 1-14 days; ecchymosis at 1 day; scabs at death or termination; ulceration at 7-14 days; sluggishness in 2 animals at 1 day; abdominal distension in 1 animal at death; recovery of affected survivor at 2 days

1.0 mL/kg bw
erythema at 1 day; edema at 1-7 days; necrosis at 1-14 days; ecchymosis on 1 animal at 1 day; scabs, ulceration at 7-14 days; desquamation on 1 animal at 14 days; abdominal distension and emaciation in 1 animal, audible breathing in 1 animal at 14 days
Body weight:
Nothing abnormal was reported.
Gross pathology:
MALES
4.0 mL/kg bw
lungs salmon-colored; trachea of 1 animal dark red; thymus of 1 animal mottled dark red; large intestines of 1 animal hemorrhaged

2.0 mL/kg bw
in deceased animal, lungs mottled salmon-colored and bright red; in survivors, lungs bright pink, salmon-colored or mottled bright pink to dark red

1.0 mL/kg bw
lungs of 1 animal dark red

FEMALES
4.0 mL/kg bw
in deceased animals, lungs salmon-colored to dark red, with dark red foci, thymus of 1 animal dark red, intestines hemorrhaged; in survivor, nothing remarkable.

2.0 mL/kg bw
in deceased animal, stomach, intestines liquid and gas-filled, small intestines hemorrhaged; in survivors, lungs salmon-colored to red, kidneys of 1 animal with a pitted surface, intestines of 1 animal gas-filled

1.0 mL/kg bw
lungs salmon-colored to dark red, 1 animal with dark red foci, stomachs and intestines of 2 animals liquid and/or gas-filled, small intestines of 1 animal hemorrhaged, abdominal cavity of 1 animal liquid-filled

Any other information on results incl. tables

The LD50 value for males was 2.46 mL/kg bw (2504 mg/kg bw) with a 95 % confidence level of 1.79-3.39 mL/kg bw (1822-3451 mg/kg bw) and a slope of 5.60. The LD50 value for females was 2.83 mL/kg bw (2881 mg/kg bw) with a 95 % confidence level of 1.61 - 4.98 mL/kg bw (1639-5070 mg/kg bw) and a slope of 3.89.

Applicant's summary and conclusion