Cyclohex-1,2-ylenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohex-1,2-ylenediamine

EC Number:

211-776-7

EC Name:

Cyclohex-1,2-ylenediamine

Cas Number:

694-83-7

Molecular formula:

C6H14N2

IUPAC Name:

cyclohexane-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): HEXAMETHVLENDIAMIN-RUECKSTAND, HMD-VORLAUF
- Analytical purity: 93.88%
- Impurities (identity and concentrations) > 0.1%: Aminoethylcyclopentylamine 3.57%, Hexamethylenimine 1.35%, Hexylmethylendiamine 0.74%, Pentylmethylendiamine 0.33%, other impurities 0.13%
- pH: 12-13 (10% aqueous solution)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae, Biberach, Germany
- Mean weight at study initiation: males 198 g, females 182 g (+- 20%)
- Fasting period before study: 16 h
- Housing: 5 per cage in stainless steel wire mesh cages, Typ DK-III
- Diet (e.g. ad libitum): Kliba-Labordiet, Klingenthalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS in fully air-conditioned rooms
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.81-21.5% (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

681, 1000, 1470 and 2150 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: several times on the day of administration and at least once each workday; check for moribund and dead animals twice each workday and once on holidays; weighing on day 0, 3, 5, 7 and 13
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 170 mg/kg bw

Based on:

test mat.

95% CL:

1 000 - 1 360

Remarks on result:

other: LD50 of male rats: ca. 1327 mg/kg bw; LD50 of female rats: ca. 1000 mg/kg bw

Mortality:

681 mg/kg bw: 0 males and 0 females died
1000 mg/kg bw: 0 males and 2 females died
1470 mg/kg bw: 4 males and all females died
2150 mg/kg bw: all animals died
All animals that died were dead within 1 day after administration

Clinical signs:

other: other: 681 mg/kg bw: no clinical signs observed 1000 mg/kg bw: dyspnea, apathy, staggering (only females), piloerection (only females) and poor general state were reversible within one day after administration 1470 mg/kg bw: dyspnea, apathy, abnormal posi

Gross pathology:

Animals-that died (male and female) :
General congestive hyperemia
Stomach/small intestines: filled with bloody contents
Glandular stomach: diffusely red (gastritis by corrosion)

Sacrificed animals (male and female):
no abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the applied test condition the test substance has an LD50 value of 1170 mg/kg bw.

Executive summary:

In a study similar to OECD guideline 401, test substance was administered via oral gavage to 5 male and 5 female Wistar rats per dose group (681, 1000, 1470 and 2150 mg/kg bw). The LD 50 value was calculated to be 1170 mg/kg bw. Clinical signs included dyspnea, apathy and poor general state.