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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to a guideline study Restriction: purity of the test material was not noted.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): monoethanolamine
- 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
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
Groups of five animals per sex (2-3 kg) were subjected to 24 hours of contact with monoethanolamine (1.0, 2.0, or 4.0 ml/kg) 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. Vetrap 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. Observations for toxicity and skin reactions were made at one hour, 7 days, and 14 days after the contact period. Animal weights were recorded at 0 days (before dose), 7 days and 14 days (just prior to termination). LD50 values and the estimated LD50 slopes were calculated by the moving average method (Thompson, 1947; Weil, 1983) and are based on a 14-day observation period. At death or termination, each animal was subjected to a gross pathologic evaluation.

Results and discussion

Preliminary study:
The LD50 value for males was 2.46 ml/kg (2504 mg/kg) with a 95% confidence level of 1.79 - 3.39 ml/kg (1822 - 3451 mg/kg) and a slope of 5.60. The LD50 value for females was 2.83 ml/kg (2881 mg/kg) with a 95% confidence level of 1.61 - 4.98 ml/kg (1639 - 5070 mg/kg) and a slope of 3.89.
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
Sex:
female
Dose descriptor:
LD50
Effect level:
2 881 mg/kg bw
95% CL:
1 639 - 5 070
Mortality:
The numbers of deaths at each dose were as follows:

Dose (ml/kg) Numbers of Animals Dead Time of Death
(M/F)
4.0 5,4 1-2 days
2.0 1,1 2, 13 days
2.0 0,0 N/A

Deaths occurred within two days, except for one female that died at 13 days.
Clinical signs:
MALES
4.00 ml/kg dosing group:
erythema, edema, necrosis, ecchymosis at 1day; prostration in 1 animal at 1 day.
2.00 ml/kg dosing group:
erythema, edema at 1 to 7 days or death; necrosis at 1 to 14 days or death; ecchymosis at 1 day, persisting on 1 to ulceration at 7 or 14 days; desquamation, alopecia on 1 at 14 days; scabs at 14 days; sluggishness at 1 day or at 7 days; emaciation of 1 at 7 days; recovery of 2 survivors after 2 days.

1.00 ml/kg dosing group:
erythema at 1 day; persisting on 1 through 7 days; edema at 1 to 7 days; ecchymosis on 1 at 1 day; necrosis at 1 to 14 days; scabs, ulceration at 7 to 14 days. No signs of systemic toxicity.

FEMALES
4.00 ml/kg dosing group:
erythema, edema, ecchymosis at 1 day to death; necrosis at 1 day to death, persisting on 1 through 14 days; scabs, ulcerations on 1 at 7 to 14 days; sluggishness at 1 day; recovery of 1 at 2 days.

2.00 ml/kg dosing group:
erythema, edema at 1 to 7 days; necrosis at 1 to 14 days; ecchymosis at 1 day; scabs at death or termination; ulceration at 7 to 14 days; sluggishness in 2 at 1 day; abdominal distension in 1 at death; recovery of affected survivor at 2 days.

1.00 ml/kg dosing group:
erythema at 1 day; edema at 1 to 7 days; necrosis at 1 to 14 days; ecchymosis on 1 at 1 day; scabs, ulceration at 7 to 14 days; desquamation on 1 at 14 days; abdominal distension and emaciation (in 1), audible breathing in 1 at 14 days.
Body weight:
Nothing abnormal reported.
Gross pathology:
MALES
4.00 ml/kg dosing group:
lungs salmon-colored; trachea of 1 animal dark red; thymus of 1 animal mottled dark red; large intestines of 1 animal hemorrhaged.

2.00 ml/kg dosing group:
in deceased animal, lungs mottled salmon-colored and bright red; in survivors, lungs bright pink, salmon-colored or mottled bright pink to dark red.

1.00 ml/kg dosing group: lungs of 1 animal dark red.

FEMALES
4.00 ml/kg dosing group:
in deceased animals, lungs salmon-colored to dark red, with dark red foci; thymus of 1 dark red; intestines hemorrhaged; in survivor, nothing remarkable.

2.00 ml/kg dosing group:
in deceased animal, stomach, intestines liquid and gas-filled; small intestines hemorrhaged; in survivors, lungs salmon-colored to red; kidneys of 1 with a pitted surface; intestines of 1 gas-filled.

1.00 ml/kg dosing group:
lungs salmon-colored to dark red, 1animal with dark red foci; stomachs and intestines of 2 animals liquid and/or gasfilled; small intestines of 1 animal hemorrhaged; abdominal cavity of 1 animal liquid-filled.

Applicant's summary and conclusion