1,2-Ethanediamine, 4-methylbenzenesulfonate (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, similar to guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Sprague-Dawley rats were exposed the test substance dissolved in water via oral gavage. After an observation period of 14 days the surviving animals were necropsied and an LD50 was determined.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenediamine

EC Number:

203-468-6

EC Name:

Ethylenediamine

Cas Number:

107-15-3

IUPAC Name:

ethane-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): Ethylenediamine
- Structural formula: H2NCH2CH2NH2

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hagemann
- Fasting period before study: 15 - 20 h
- Diet: Herilan MRH; H.Eggermann KG
-Weight at study initiation: Mean of different dose groups: Males: 140-300g; Females: 160-220g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 3.16, 4.64, 6.81, 8.25, 10, 12.1, 14.7 % (w/v)
- Administration volume: 10 mL/kg

Doses:

316, 464, 681, 825, 1000, 1210, 1470 mg/kg

No. of animals per sex per dose:

- 316, 464, 681 mg/kg: 5
- 825, 1000, 1210, 1470 mg/kg: 10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

841 mg/kg bw

Based on:

test mat.

95% CL:

683 - 943

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

893 mg/kg bw

Based on:

test mat.

95% CL:

750 - 1 001

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

866 mg/kg bw

Based on:

test mat.

95% CL:

762 - 946

Mortality:

- No mortality observed in animals exposed to 316, 464 or 681 mg/kg.
- 6 out of 10 male and 5 out of 10 female animals died exposed to 825 mg/kg.
- 8 out of 10 male and 7 out of 10 female animals died exposed to 1000 mg/kg.
- 9 out of 10 male and 8 out of 10 female animals died exposed to 1210 mg/kg.
- 9 out of 10 male and all female animals died exposed to 1470 mg/kg.

Clinical signs:

other: - Dyspnea, spasmodic respiration, apathy, abnormal position, staggering, spastic gait, piloerection, diarrhea, cyanosis, exsiccosis, and a poor general state were observed in animals exposed to 1470 mg/kg. The surviving animal was without symptoms after 2

Gross pathology:

- Animals that died: Heart: acute dilatation on the right side; acute congestion; Stomach: diffuse reddening of the glandular stomach; Intestine: in individual animals diarrheal content; atonic; reddened in several cases; Liver: in some animals individual focal necrosis; Thymus: in individual animals extensive hemorrhages.
- Sacrificed animals: Stomach: in several animals wall of the forestomach slightly indurated. In individual cases adhesion of the forestomach to the liver.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information

Conclusions:

Under the conditions of this test, the LD50 was determined to be 841, 893, and 866 mg/kg bw for male, female rats and all rats combined, respectively.

Executive summary:

Five Sprague-Dawley rats per sex per dose were exposed to 316, 464 or 681 mg/kg bw of the test substance dissolved in water via oral gavage. Ten Sprague-Dawley rats per sex per dose were exposed to 825, 1000, 1250 or 1470 mg/kg. After an observation period of 14 days the surviving animals were necropsied. Dyspnea, spasmodic respiration, apathy, abnormal position, staggering, spastic gait, orange-yellow urine, piloerection, diarrhea, cyanosis, exsiccosis, salivation, blood in the feces and a poor general condition were observed amongst exposed animals. Acute dilation on the right side and acute congestion of the heart, diffuse reddening of the glandular stomach, diarrheal content, atonic and reddened intestine in several cases, and extensive hemorrhages of the thymus were observed amongst animals that died upon necropsy. In several sacrificed animals a slightly indurated forestomach and adhesion of the forestomach to the liver were observed upon necropsy. The LD50 was determined to be 841 and 893 mg/kg bw for male and female rats, respectively. The LD50 was determined to be 866 mg/kg bw for male and female animals combined.