1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-C7-17-alkyl derivs.

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

Study period:

Oct-Nov 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited information on test material and study conditions, but the study met the general principles of acute toxicity study although prior to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

deviations (lack of reported data, no body weight, no clinical signs or necropsy findings)

GLP compliance:

no

Remarks:

Prior to GLP principles

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

EC Number:

267-058-9

EC Name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

Cas Number:

67784-90-1

IUPAC Name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

Test animals

Species:

mouse

Strain:

CF-1

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 18-21g
- Fasting period before study: no data
- Housing: wire cages, 5 animals per cage
- Diet (e.g. ad libitum): Lab Blox, ad libitum
- Water (e.g. ad libitum): as libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data (test material received on October 25, 1978).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: none used

MAXIMUM DOSE VOLUME APPLIED: 2.5 ml/kg

DOSAGE PREPARATION (if unusual): no data

Doses:

1.25, 1.67 and 2.5 mL/kg bw (corresponding to 1175, 1570 and 2350 mg/kg bw using a specific gravity of ca. 0.94 at 25 °C)

No. of animals per sex per dose:

10 animals per dose (sex unknown)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data

Statistics:

LD50 calculated using (CHI)2 following the method of Litchfield VT and Wilcoxon F.
J. Pharmacol. Exper. Therapeutics, vol. 96, p.99, 1949.

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1.61 mL/kg bw

Based on:

test mat.

95% CL:

1.31 - 1.98

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 513 mg/kg bw

Based on:

test mat.

95% CL:

1 231 - 1 861

Remarks on result:

other: Assuming specific gravity 0.94 at 25 C (company data).

Mortality:

See table under “other information”

Clinical signs:

other: no data

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

Results

Group	Dose (mL/kg bw)	Mortality	Group mortality (%)
1	1.25	2/10	20
2	1.67	6/10	60
3	2.5	8/10	80

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 oral (mice): 1513 mg/kg bw

Executive summary:

The test material was assessed for acute oral toxicity in 10 mice (sex unspecified) weighing 18 to 21 g. The test substance was administered at 1.25, 1.67 and 2.5 ml/kg bw by gavage. The animals were observed for 5 days. Mortality occurred in all dose groups, with two, six and eight animals found dead in the groups administered 1.25, 1.67 and 2.5 ml/kg bw, respectively. The acute oral LD50 of the test material was estimated to be 1.61 ml/kg bw (ca. 1513 mg/kg bw) in mice.

The substance is considered harmful by ingestion, Xn, R22, according to the criteria of Annex VI to Directive 67/548/EEC, or Acute tox. 4, H302 according to EU Regulation 1272/2008 (CLP).